osimertinib

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Biomarkers

Sponsors

Industry sponsors leading active biomarker-selected trials of osimertinib.

1. AstraZeneca 19
2. Baili-Bio / SystImmune 4
3. AbbVie 3
4. Shanghai JMT-Bio 3
5. CSPC 2
6. Bristol Myers Squibb 2
7. Kelun-Biotech 2
8. TYK Medicines 2
9. Jiangsu Aosaikang Pharmaceutical 1
10. Allist Pharmaceuticals 1
11. HUTCHMED 1
12. Eli Lilly 1

Trials

123 of 223 trials shown

1. Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.

   Recruiting Phase 4 AstraZeneca Started 2026Primary completion 2030-05 NCT07279935

   osimertinib FDA EUcisplatincarboplatinpemetrexed

   EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue i…

   EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

2. Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer

   Recruiting Phase 3 National Taiwan University Hospital Started 2026Primary completion 2031-08 NCT07738172

   osimertinib FDA EU

   EGFR sensitizing mutation limited to exon 19 deletion or exon 21 L858R.

   EGFR exon 19 deletion / L858RLung Neoplasms, Non-Small Cell Lung Cancer

3. A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC

   Not yet recruiting Phase 3 CSPC Started 2026Primary completion 2026-12 NCT07376382

   SYS6010osimertinib FDA EUpemetrexed

   Carry at least one EGFR-sensitive mutation (ex19del or L858R, which can be combined with other EGFR mutations).

   EGFR exon 19 deletion / L858RNSCLC

4. ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

   Not yet recruiting Phase 3 Jiangsu Aosaikang Pharmaceutical Started 2026Primary completion 2030-12 NCT07897188

   ASKC202ASKC202 placeboosimertinib FDA EUpemetrexedcisplatincarboplatinlimertinib

   The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R).

   EGFR exon 19 deletion / L858REGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), MET Positive

5. Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

   Recruiting Phase 3 Bristol Myers Squibb Started 2026Primary completion 2031-12 NCT07680790

   izalontamab brengitecanosimertinib FDA EUpemetrexedcarboplatincisplatin

   Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

6. A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

   Recruiting Phase 3 Baili-Bio / SystImmune Started 2026Primary completion 2030-12 NCT07640789

   izalontamab brengitecanosimertinib FDA EU

   …With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definiti…

   EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer Stage III

7. A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

   Recruiting Phase 2/3 Baili-Bio / SystImmune Started 2026Primary completion 2032-12 NCT07642024

   izalontamab brengitecanosimertinib FDA EUcarboplatinpemetrexedcisplatin

   …udy of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

   EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

8. A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

   Recruiting Phase 2/3 AbbVie Started 2025Primary completion 2036-11 NCT07005102

   telisotuzumab adizutecanosimertinib FDA EUcisplatincarboplatinpemetrexed

   …d metastatic/locally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by…

   EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer, c-MET

9. A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

   Recruiting Phase 2/3 AbbVie Started 2025Primary completion 2030-09 NCT07155187

   telisotuzumab adizutecanosimertinib FDA EU

   …vanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer, c-MET

10. A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2025Primary completion 2028-12 NCT06838273

    izalontamab brengitecanosimertinib FDA EU

    …sue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

11. Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients

    Not yet recruiting Phase 2/3 Shanghai JMT-Bio Started 2025Primary completion 2028-12 NCT06908772

    glumetinibosimertinib FDA EU

    …ined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

    EGFR exon 19 deletion / L858RRecurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

12. A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases

    Recruiting Phase 3 Allist Pharmaceuticals Started 2024Primary completion 2029-03 NCT06970639

    furmonertinibcarboplatincisplatinpemetrexedosimertinib FDA EU

    Confirmed EGFR sensitizing mutations (ex19del or L858R) via tumor tissue/cytology/blood testing;

    EGFR exon 19 deletion / L858RNSCLC Patients With Brain Metastasis

13. Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)

    Not yet recruiting Phase 3 Fudan University Started 2024Primary completion 2026-03 NCT06323148

    osimertinib FDA EUNo adjuvant therapy

    …lar testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-03-21Lung Cancer, EGFR Gene Mutation, Minimal Residual Disease

14. A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2027-01 NCT06417814

    datopotamab deruxtecan FDAosimertinib FDA EUpemetrexedcarboplatincisplatin

    …pidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutation…

    EGFR exon 19 deletion / L858RMetastatic Non-small Cell Lung Cancer

15. Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

    Recruiting Phase 3 AstraZeneca Started 2024Primary completion 2028-03 NCT06350097

    osimertinib FDA EUdatopotamab deruxtecan FDA

    … least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may inclu…

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

16. A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 Kelun-Biotech Started 2024Primary completion 2027-05 NCT06670196

    sacituzumab tirumotecanosimertinib FDA EU

    …on With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

17. JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations

    Not yet recruiting Phase 3 Shanghai JMT-Bio Started 2024Primary completion 2027-03 NCT06380348

    JMT101osimertinibcisplatinpemetrexed

    For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.

    EGFR exon 20 insertionStatus may be outdated, last updated 2024-04-23Local Advanced or Metastatic NSCLC

18. A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

    Active, not recruiting Phase 3 AstraZeneca Started 2022Primary completion 2027-08 NCT05120349

    osimertinib FDA EU

    A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

19. Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

    Active, not recruiting Phase 3 AstraZeneca Started 2022Primary completion 2026-07 NCT05261399

    savolitinibosimertinib FDA EUpemetrexedcisplatincarboplatin

    Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

20. Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

    Recruiting Phase 3 TYK Medicines Started 2022Primary completion 2025-05 NCT05382728

    TY-9591osimertinib FDA EU

    Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites)…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-01-30NSCLC, EGFR Activating Mutation

21. EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

    Recruiting Phase 3 Region Skane Started 2022Primary completion 2028-09 NCT06486142

    afatinib FDA EUdacomitinib FDA EUosimertinib FDA EU

    EGFR-mutation in tumor (in cases where tumor tissue is not available for mutation analysis, circulating…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

22. SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

    Active, not recruiting Phase 2/3 Baili-Bio / SystImmune Started 2022Primary completion 2025-12 NCT05020769

    SI-B001osimertinib

    …all cell lung cancer (NSCLC) confirmed by histopathology and/or cytology, T790M-negative, Exon20ins mutation resistant to the third generation EGFR TKI after the first or second line treatm…

    EGFR exon 20 insertionNon-small Cell Lung Cancer

23. A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2024-10 NCT04765059

    osimertinib FDA EUpemetrexedcisplatincarboplatin

    …) mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T7…

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

24. Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations

    Active, not recruiting Phase 3 Li Zhang, MD Started 2021Primary completion 2025-11 NCT04695925

    osimertinib FDA EUpemetrexedcarboplatin

    …V or recurrent non-squamous non-small cell lung carcinoma with activating EGFR mutations (exon 19 deletion or exon 21 L858R point mutation) and concurrent TP53 mutations;

    EGFR exon 19 deletion / L858RNon-small Cell Carcinoma, EGFR Gene Mutation

25. Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

    Active, not recruiting Phase 3 HUTCHMED Started 2021Primary completion 2028-05 NCT05009836

    savolitinibosimertinib FDA EU

    …arrying two common EGFR mutations clearly related with the sensitivity to EGFR-TKI (i.e., exon 19 deletion, and L858R) and c-MET overexpression

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

26. A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2020Primary completion 2024-10 NCT04351555

    osimertinib FDA EUcisplatincarboplatinpemetrexed

    …ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exo…

    EGFR exon 19 deletion / L858REGFR exon 20 insertionNon-Small Cell Lung Cancer

27. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 Johnson & Johnson Started 2020Primary completion 2023-08 NCT04487080

    amivantamab FDA EUosimertinib FDA EUlazertinib FDA EU

    The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administrati…

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

28. A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

    Active, not recruiting Phase 3 AstraZeneca Started 2019Primary completion 2023-04 NCT04035486

    osimertinib FDA EUpemetrexedcarboplatincisplatin

    … with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EG…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

29. A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

    Active, not recruiting Phase 3 AstraZeneca Started 2018Primary completion 2024-01 NCT03521154

    osimertinib FDA EU

    …rs one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas® EGF…

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer (Stage III)

30. A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

    Active, not recruiting Phase 3 Eli Lilly Started 2015Primary completion 2019-01 NCT02411448

    ramucirumab FDA EUerlotinib FDA EUgefitinib FDA EUosimertinib FDA EU

    …h erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].

    EGFR exon 19 deletion / L858RMetastatic Non-Small Cell Lung Cancer

31. AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

    Active, not recruiting Phase 3 AstraZeneca Started 2015Primary completion 2022-04 NCT02511106

    osimertinib FDA EU

    …ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.

    EGFR exon 19 deletion / L858RStage IB-IIIA Non-small Cell Lung Carcinoma

32. Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

    Recruiting Phase 1/2 Misty Shields Starts 2027Primary completion 2029-04 NCT07153055

    Lurbinectedinosimertinib FDA EU

    Must have an initial diagnosis of EGFR altered (EGFR-mutated) non-small cell lung cancer and received EGFR targeted therapy (TKI) osimer…

    EGFR exon 19 deletion / L858RSmall Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer

33. Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer

    Recruiting Phase 2 Chinese University of Hong Kong Started 2026Primary completion 2029-03 NCT07379476

    osimertinib FDA EU

    Positive for EGFR exon 19 deletion or EGFR exon 21 L858R mutation (either by tissue or plasma testing)

    EGFR exon 19 deletion / L858RLung Cancer (NSCLC)

34. Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study

    Recruiting Phase 2 AstraZeneca Started 2026Primary completion 2029-05 NCT07295821

    osimertinib FDA EU

    …arbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo T790M

    EGFR exon 19 deletion / L858RLung Cancer

35. Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-Mutated Lung Cancer

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2028-01 NCT07505173

    osimertinib FDA EU

    …e test confirmed EGFR sensitive mutations, including exon 19 deletion (19del) and exon 21 L858R mutation (verified and confirmed by investigators at the respective study centers);

    EGFR exon 19 deletion / L858RNaive Advanced Non-small Cell Lung Cancer With EGFR-sensitive Mutations (EGFR Exon 19 Deletion and Exon 21 L858R Mutation) and Symptomatic Brain Metastases

36. Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer

    Recruiting Phase 2 Jonsson Comprehensive Cancer Center Started 2026Primary completion 2027-02 NCT07323641

    osimertinib FDA EUtelisotuzumab vedotin

    Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to osimertinib.

    EGFR exon 19 deletion / L858RLung Non-Small Cell Carcinoma

37. Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

    Not yet recruiting Phase 1/2 Innovent Biologics Started 2026Primary completion 2027-06 NCT07612137

    IBI3005sintilimabbevacizumablimertinibosimertinib FDA EUcarboplatin

    Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology speci…

    EGFR exon 19 deletion / L858RSolid Tumor

38. Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLC

    Recruiting Phase 2 NYU Langone Health Started 2026Primary completion 2030-12 NCT07874490

    osimertinib FDA EUCyclosporine A (CsA)

    Somatic activating mutation in EGFR exon 19 deletion or EGFR L858R in pre-treatment tumor biopsy or cytology from pleural fluid or cfDNA as de…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

39. Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib

    Not yet recruiting Phase 1/2 Shanxi Province Cancer Hospital Started 2026Primary completion 2028-10 NCT07486648

    capivasertibosimertinib FDA EU

    Documented EGFR sensitive mutations (exon19 deletion, L858R mutation) prior to the first-line EGFR-TKI therapy.

    EGFR exon 19 deletion / L858RPIK3CA activating mutationLung Cancer (NSCLC), Lung Cancer (Non-Small Cell), Advanced Non-small-cell Lung Cancer

40. Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

    Recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2027-08 NCT07329322

    sacituzumab tirumotecanosimertinib FDA EU

    Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

41. A Phase 2 Study of ABSK043 Combined With Osimertinib

    Not yet recruiting Phase 2 Abbisko Therapeutics Started 2026Primary completion 2029-12 NCT07710612

    osimertinib FDA EU

    Documented genetic testing report confirms the presence of EGFR alteration(s) in tumor or plasma.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive

42. A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

    Not yet recruiting Phase 1/2 Beijing Pearl Biotechnology Started 2026Primary completion 2029-12 NCT07285148

    PLB1004osimertinib FDA EU

    Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples …

    EGFR exon 19 deletion / L858REGFR exon 20 insertionNon-Small Cell Lung Cancer, EGFR Mutation, Metastatic Lung Cancer, MET Alteration

43. Boosting Osimertinib Blood Brain Barrier Penetration

    Recruiting Phase 2 Maastricht University Medical Center Started 2026Primary completion 2027-06 NCT07485452

    osimertinib FDA EU

    The patient has metastatic EGFR-mutated NSCLC and is treated with osimertinib as part of regular care with CT-confirmed stable di…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

44. A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer

    Recruiting Phase 1/2 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2028-04 NCT07535437

    ivonescimabdatopotamab deruxtecan FDAosimertinib FDA EU

    A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

45. A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC

    Recruiting Phase 2 Shanghai Chest Hospital Started 2025Primary completion 2029-01 NCT07058519

    osimertinib FDA EU

    …dvanced or metastatic non-squamous NSCLC with sensitizing EGFR mutations positive (either Exon 19 deletion or 21 L858R, confirmed by histology or cytology), and classified as stage IIIB, IIIC, IV …

    EGFR exon 19 deletion / L858RLocally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC)

46. A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2031-02 NCT06618287

    izalontamab brengitecanosimertinib FDA EUpembrolizumabnivolumabpumitamig

    …ants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, w…

    EGFR exon 19 deletion / L858RLung Cancer, Breast Cancer

47. Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma

    Not yet recruiting Phase 2 The University of Hong Kong Started 2025Primary completion 2027-12 NCT06918782

    osimertinib FDA EU

    Confirmed EGFR common sensitizing mutations (exon 21 L858R or exon 19 del) by locally approved molecular testing methods (allele-specific PCR or NGS) based on tumo…

    EGFR exon 19 deletion / L858RLung Cancer (NSCLC)

48. Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

    Recruiting Phase 1/2 Dizal Pharmaceuticals Started 2025Primary completion 2028-06 NCT07079475

    DZD6008sunvozertinibosimertinib FDA EU

    Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

49. A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2025Primary completion 2028-06 NCT07375316

    osimertinib FDA EUsacituzumab tirumotecan

    Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R);

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

50. A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

    Not yet recruiting Phase 2 CSPC Started 2025Primary completion 2026-11 NCT07256509

    SYS6010osimertinib FDA EUpemetrexedcisplatincarboplatin

    …mbined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

51. Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer

    Not yet recruiting Phase 2 Jianxing He Started 2025Primary completion 2028-10 NCT07177092

    osimertinib FDA EU

    Presence of EGFR exon 19 deletion (19Del) or L858R mutation, confirmed by ARMS-PCR, NGS, or other validated methods.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer, EGFR

52. Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification

    Recruiting Phase 2 Qingdao Central Hospital Started 2025Primary completion 2026-12 NCT07322783

    savolitinibosimertinib FDA EU

    Osimertinib Combined With Savolitinib in the Treatment of EGFR Mutated Osimertinib Resistant NSCLC With Low Copy Number MET Amplification

    EGFR exon 19 deletion / L858REGFR Positive Non-small Cell Lung Cancer, MET Amplification

53. A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

    Not yet recruiting Phase 2 Wen-zhao ZHONG Started 2025Primary completion 2027-12 NCT07038460

    limertinibsintilimabosimertinib FDA EU

    …ollowed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

    EGFR exon 19 deletion / L858RResectable Non-small Cell Lung Cancer

54. Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

    Not yet recruiting Phase 2 Peking Union Medical College Hospital Started 2024Primary completion 2027-01 NCT06752408

    aumolertinibosimertinib FDA EU

    … effusion, ascites, cerebrospinal fluid) with at least one sensitizing mutation (L858R or 19Del).

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

55. Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

    Recruiting Phase 2 Avistone Biotechnology Started 2024Primary completion 2026-10 NCT06574347

    vebreltinibosimertinib FDA EUPLB1004

    Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .

    EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer

56. To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations

    Active, not recruiting Phase 2 AstraZeneca Started 2024Primary completion 2026-07 NCT06194448

    osimertinib FDA EUcisplatincarboplatinpemetrexedpaclitaxelRadiation

    …rs one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo T790M

    EGFR exon 19 deletion / L858RLung Cancer

57. Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC

    Active, not recruiting Phase 2 National Cancer Center Started 2024Primary completion 2026-09 NCT06827145

    vebreltinibosimertinib FDA EU

    4.EGFR 21 L858R mutation.

    EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer

58. Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC

    Not yet recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Started 2024Primary completion 2029-06 NCT06436144

    osimertinib FDA EUetoposide

    Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R).

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-05-30Non Small Cell Lung Cancer, EGFR Gene Mutation, Non Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV

59. Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer.

    Not yet recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2024Primary completion 2027-12 NCT06452433

    glumetinibosimertinib FDA EUaumolertinibfurmonertinib

    Patients with EGFR mutations known to be associated with drug sensitivity (i.e., exon 19 deletion or L858R mutation).

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-06-11Non-small Cell Lung Cancer

60. A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

    Recruiting Phase 1/2 Suzhou Genhouse Bio Started 2024Primary completion 2025-12 NCT06306456

    GH21osimertinib FDA EU

    Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-07-08Non-Small Cell Lung Cancer With EGFR Mutation

61. Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

    Recruiting Phase 2 The First Affiliated Hospital of Guangzhou Medical University Started 2024Primary completion 2025-10 NCT06383728

    osimertinib FDA EU

    Gene text confirmed EGFR mutation;

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-05-09Lung Cancer, Carcinoma, Squamous Cell

62. A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2024Primary completion 2027-12 NCT06741085

    osimertinib FDA EU

    Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer Metastatic

63. Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

    Recruiting Phase 1/2 China Medical University Hospital Started 2024Primary completion 2026-08 NCT06071013

    gefitinib FDA EUerlotinib FDA EUafatinib FDA EUosimertinib FDA EU

    Positive EGFR mutations are diagenesis.

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, EGFR Gene Mutation, EGFR-TKI Resistant Mutation

64. Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2024Primary completion 2025-12 NCT06363734

    osimertinib FDA EU

    Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistan…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-04-16Non-small Cell Lung Cancer, EGFR Activating Mutation, Cell Cycle Deregulation, EGFR-TKI Resistant Mutation

65. High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases

    Not yet recruiting Phase 2 Taizhou Hospital Started 2024Primary completion 2026-12 NCT06319950

    furmonertinibosimertinib FDA EU

    The tissue or blood sample is determined to be EGFR positive (including rare EGFR mutations) by testing by a tertiary Class A hospital or a qualified testing institution, and the ti…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-03-20Lung Cancer, Nonsmall Cell

66. A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

    Active, not recruiting Phase 2 AstraZeneca Started 2023Primary completion 2029-11 NCT05526755

    osimertinib FDA EU

    …on by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR …

    EGFR exon 19 deletion / L858RStage II-IIIB Non-small Cell Lung Carcinoma

67. A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations

    Active, not recruiting Phase 2 AstraZeneca Started 2023Primary completion 2027-10 NCT05801029

    osimertinib FDA EUamivantamab FDA EU

    …icacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer (NSCLC)

68. A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC

    Active, not recruiting Phase 2 National Cancer Centre, Singapore Started 2023Primary completion 2025-10 NCT05773092

    osimertinib FDA EU

    Patients must have histologically or cytologically confirmed EGFR mutant NSCLC.

    EGFR exon 19 deletion / L858RNSCLC

69. A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

    Active, not recruiting Phase 2 Klus Pharma Started 2023Primary completion 2026-06 NCT05816252

    sacituzumab tirumotecanpembrolizumabcarboplatinosimertinib FDA EU

    or confirmed to harbor EGFR mutation;

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

70. Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

    Recruiting Phase 2 SWOG Cancer Research Network Started 2023Primary completion 2027-06 NCT05642572

    capmatinibosimertinib FDA EUramucirumab FDA EU

    Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physicia…

    EGFR exon 19 deletion / L858RRecurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

71. TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

    Recruiting Phase 2 TYK Medicines Started 2023Primary completion 2025-12 NCT05948813

    TY-9591osimertinib FDA EU

    Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites)…

    EGFR exon 19 deletion / L858RNSCLC, EGFR Activating Mutation, Brain Metastases

72. The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC

    Recruiting Phase 1/2 Hunan Province Tumor Hospital Started 2023Primary completion 2026-12 NCT06109558

    osimertinib

    Cohort A：MET amplification,(by FISH, NGS or IHC) Cohort B：RET fusion.

    RET fusion or mutationStatus may be outdated, last updated 2024-05-30Non Small Cell Lung Cancer, RET Gene Mutation, MET Amplification, EGF-R Positive Non-Small Cell Lung Cancer

73. Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)

    Recruiting Phase 2 Samsung Medical Center Started 2022Primary completion 2027-09 NCT04591002

    osimertinib FDA EU

    …ed lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.

    EGFR exon 19 deletion / L858RLung Cancer

74. Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

    Recruiting Phase 2 Samsung Medical Center Started 2022Primary completion 2027-09 NCT05528458

    osimertinib FDA EU

    …ed lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.

    EGFR exon 19 deletion / L858RLung Adenocarcinoma

75. Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2022Primary completion 2024-10 NCT05686434

    osimertinib FDA EU

    …ns one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M;

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-01-17NSCLC, Stage I

76. Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 1/2 Washington University School of Medicine Started 2022Primary completion 2027-01 NCT04743505

    vebreltinibosimertinib FDA EU

    …ncer, or locally advanced disease that is not amendable for curative intent therapy, with TKI-sensitive EGFR mutation through CLIA certified lab.

    EGFR exon 19 deletion / L858RMetastatic Non Small Cell Lung Cancer

77. Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

    Active, not recruiting Phase 2 AIO-Studien-gGmbH Started 2022Primary completion 2026-03 NCT05089916

    osimertinib FDA EU

    …ding to marketing authorization (first line treatment of tumor positive for a common or uncommon EGFR mutation, or later line treatment of tumor positive for EGFR T790M mutation, assessed according to…

    EGFR exon 19 deletion / L858RNSCLC, EGFR Positive Non-small Cell Lung Cancer, Oligoprogression

78. Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Jonsson Comprehensive Cancer Center Started 2021Primary completion 2026-12 NCT04285671

    necitumumabosimertinib FDA EUtrastuzumab

    Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to EGFR tyrosine k…

    EGFR exon 19 deletion / L858RMetastatic Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8, Stage IVA Lung Cancer AJCC v8

79. Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)

    Recruiting Phase 2 Goethe University Started 2021Primary completion 2025-11 NCT05281406

    osimertinib FDA EUpemetrexedcisplatincarboplatin

    Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.

    EGFR exon 19 deletion / L858RNSCLC Stage IIIB, NSCLC Stage IV

80. Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

    Recruiting Phase 2 Sun Yat-sen University Started 2021Primary completion 2023-09 NCT05011487

    osimertinib FDA EUcisplatinpemetrexed

    …ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-01-16Non-Small Cell Lung Cancer

81. Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

    Recruiting Phase 1/2 Vivace Therapeutics Started 2021Primary completion 2029-11 NCT04665206

    VT3989nivolumabipilimumabosimertinib FDA EUpemetrexedcarboplatin

    … diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.

    EGFR exon 19 deletion / L858RSolid Tumor, Adult, Mesothelioma, NSCLC

82. JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations

    Active, not recruiting Phase 2 Shanghai JMT-Bio Started 2021Primary completion 2023-05 NCT06391944

    JMT101osimertinib FDA EU

    … to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV) harbouring EGFR common mutation with tumour tissue/blood sample.

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-04-30Local Advanced or Metastatic NSCLC, Harboring EGFR Common Mutation

83. Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge

    Recruiting Phase 2 Mark Vincent Started 2021Primary completion 2026-06 NCT04335292

    osimertinib FDA EUpemetrexed

    Patients must have a known activating Epidermal Growth Factor Receptor (EGFR) mutation.

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-10-22Non-Small Cell Lung Cancer

84. Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib

    Recruiting Phase 1/2 Genprex Started 2021Primary completion 2028-03 NCT04486833

    quaratusugene ozeplasmidosimertinib FDA EUcisplatincarboplatin

    The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent evaluati…

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small Cell Lung

85. Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 National Cancer Institute (NCI) Started 2020Primary completion 2024-06 NCT03831932

    osimertinib FDA EUTelaglenastat Hydrochloride

    Activating mutation present in the EGFR gene (L858R or exon 19 deletion, alone or in combination with other EGFR mutations) as per local assessment of a tissue b…

    EGFR exon 19 deletion / L858RAdvanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

86. Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance

    Active, not recruiting Phase 2 University of California, San Diego Started 2020Primary completion 2025-12 NCT04545710

    abemaciclibosimertinib FDA EU

    Tumor must harbor an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q).

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-08-05Lung Cancer

87. Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2020Primary completion 2027-05 NCT04410796

    osimertinib FDA EUcarboplatinpemetrexed

    Patients with detectable plasma EGFR mutations at C2D1

    EGFR exon 19 deletion / L858RMetastatic Non-small Cell Lung Cancer

88. A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC

    Active, not recruiting Phase 2 AstraZeneca Started 2020Primary completion 2022-12 NCT04606771

    osimertinib FDA EUsavolitinib

    …Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

89. Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

    Active, not recruiting Phase 2 British Columbia Cancer Agency Started 2019Primary completion 2025-04 NCT03769103

    osimertinib FDA EU

    Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGF…

    EGFR exon 19 deletion / L858RLung Cancer Non-small Cell Stage IV, Brain Metastases

90. Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 2 Xiuning Le Started 2019Primary completion 2026-12 NCT03909334

    osimertinib FDA EUramucirumab FDA EU

    NSCLC which harbours EGFR Exon 19 deletion.

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer, EGFR Gene Mutation, Advanced Cancer, Metastatic Cancer

91. Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib

    Active, not recruiting Phase 2 AstraZeneca Started 2019Primary completion 2024-08 NCT03778229

    osimertinib FDA EUsavolitinib

    …with EGFR TKI sensitivity and permitted in the osimertinib national label (such as either exon 19 deletion and/or L858R) which is not amenable to curative therapy.

    EGFR exon 19 deletion / L858RCarcinoma

92. A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2018Primary completion 2027-06 NCT03392246

    osimertinib FDA EUselumetinib

    …e histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory.

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

93. Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery

    Active, not recruiting Phase 2 University of California, San Francisco Started 2018Primary completion 2023-01 NCT03433469

    osimertinib FDA EU

    Documented activating EGFR mutation (Exon 19 deletion, T790M, or L858R) on tumor samples by Clinical Laboratory Clinical Laboratory Improvement…

    EGFR exon 19 deletion / L858RStage I Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer, Stage IB Non-Small Cell Lung Cancer, Stage II Non-Small Cell Lung Cancer

94. Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2018Primary completion 2027-04 NCT03410043

    osimertinib FDA EU

    NSCLC which harbors EGFR exon 19 deletion or L858R mutation.

    EGFR exon 19 deletion / L858RLung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

95. Osimertinib In EGFR Mutant Lung Cancer

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2018Primary completion 2028-02 NCT03586453

    osimertinib FDA EU

    …e histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory from tumor tissue.

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

96. Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2025-02 NCT02971501

    bevacizumabosimertinib FDA EU

    Non-small cell lung cancer (NSCLC) with an activating EGFR mutation (exon 19 deletion, L858R point mutation, or any other mutation known to be associated with EGFR TKI sensiti…

    EGFR exon 19 deletion / L858RMetastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8

97. Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study

    Active, not recruiting Phase 1/2 AstraZeneca Started 2018Primary completion 2021-05 NCT03381274

    oleclumabosimertinib FDA EUAZD4635

    …sed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFRm

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

98. Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC

    Active, not recruiting Phase 2 University of Texas Southwestern Medical Center Started 2018Primary completion 2027-09 NCT03667820

    osimertinib FDA EU

    EGFR mutations may be demonstrated by standard, clinically accepted methods, including direct gene seque…

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer (NSCLC)

99. Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2027-06 NCT03191149

    osimertinib FDA EU

    Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

    EGFR exon 19 deletion / L858REGFR exon 20 insertionAdvanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7

100. Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

     Active, not recruiting Phase 1/2 Dana-Farber Cancer Institute Started 2017Primary completion 2026-10 NCT03122717

     gefitinib FDA EUosimertinib FDA EU

     …e histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory.

     EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

101. Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)

     Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2016Primary completion 2023-02 NCT06303167

     osimertinib FDA EU

     …mertinib (AZD9291) in Patients With Tumors Having EGFR T790M Mutations or Rare Activating Mutations of EGFR

     EGFR exon 19 deletion / L858RAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

102. Zorifertinib With Osimertinib for NSCLC With Meningeal Progression

     Recruiting Phase 1 Alpha Biopharma Started 2026Primary completion 2028-04 NCT07361705

     osimertinib FDA EU

     …riod, subjects must have a previous histological or cytological diagnosis of NSCLC with a sensitising EGFR mutation (including L858R and/or Exon19Del).

     EGFR exon 19 deletion / L858RPatients With Advanced Non-small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment

103. Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

     Recruiting Phase 1 Nuvectis Pharma Started 2025Primary completion 2026-12 NCT07315113

     NXP900osimertinib FDA EU

     Unresectable, metastatic or locally advanced EGFR-mutated NSCLC.

     EGFR exon 19 deletion / L858REGFR Mutation Positive Non-small Cell Lung Cancer, EGFR Mutated Non-small Cell Lung Cancer Patients

104. Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

     Not yet recruiting Phase 1 Jonathan Riess Started 2024Primary completion 2025-01 NCT06067776

     cetuximabosimertinib FDA EUtucatinib

     NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, Exon 20 S768I.

     EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-10-05Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

105. A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

     Active, not recruiting Phase 1 Kumquat Biosciences Started 2024Primary completion 2026-12 NCT06507306

     KQB198osimertinib FDA EUamivantamab FDA EU

     … arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib

     EGFR exon 19 deletion / L858REGFR exon 20 insertionSolid Tumor, Adult

106. Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

     Recruiting Phase 1 Karen Reckamp, MD, MS Started 2023Primary completion 2028-01 NCT05401110

     osimertinib FDA EUCarotuximab

     Stage IV or recurrent/metastatic non-squamous NSCLC that harbors an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, etc).

     EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer, Lung Cancer

107. Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

     Recruiting Phase 1 BioNTech Started 2022Primary completion 2030-02 NCT05142189

     BNT116cemiplimabdocetaxelcarboplatinpaclitaxelgotistobartanti-B7-H3 antibody conjugated to topoisomerase I inhibitoranti-HER3 antibody conjugated to topoisomerase I inhibitorBispecific antibody for PD-L1 and VEGF-Aosimertinib FDA EUALK-inhibitor or RET-inhibitor

     Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.

     EGFR exon 19 deletion / L858RALK fusionRET fusion or mutationNon-Small Cell Lung Cancer

108. Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer

     Active, not recruiting Phase 1 City of Hope Medical Center Started 2022Primary completion 2027-10 NCT05166616

     osimertinib FDA EUTriptolide Analog

     … with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EG…

     EGFR exon 19 deletion / L858RAdvanced Lung Non-Small Cell Carcinoma, Locally Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8

109. Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer

     Recruiting Phase 1 Ohio State University Comprehensive Cancer Center Started 2022Primary completion 2026-12 NCT04780568

     osimertinib FDA EUTegavivint

     A common activating mutation must be present in the EGFR gene, i.e., exon 19 deletion or L858R.

     EGFR exon 19 deletion / L858RMetastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

110. First in Human Study of AZD9592 in Solid Tumors

     Active, not recruiting Phase 1 AstraZeneca Started 2022Primary completion 2026-06 NCT05647122

     AZD9592osimertinib FDA EUfluorouracilleucovorinbevacizumab

     Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC

     EGFR exon 19 deletion / L858RAdvanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms, Colorectal Neoplasms

111. HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

     Active, not recruiting Phase 1 Daiichi Sankyo Started 2021Primary completion 2025-01 NCT04676477

     patritumab deruxtecanosimertinib FDA EU

     Documentation of EGFR exon 19 deletion or L858R mutation detected from tumor tissue

     EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer (NSCLC)

112. MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer

     Recruiting Phase 1 Emory University Started 2021Primary completion 2026-12 NCT04762199

     Flt3/MerTK Inhibitor MRX-2843osimertinib FDA EU

     …nts must have histologically confirmed metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation including typical and atypical mutations in egfr exons 19 and 21

     EGFR exon 19 deletion / L858RAdvanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8

113. Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

     Active, not recruiting Phase 1 University of Utah Started 2020Primary completion 2024-01 NCT04141644

     ipilimumabosimertinib FDA EU

     Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

     EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)

114. A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients

     Active, not recruiting Phase 1 Ascentage Pharma Group Started 2019Primary completion 2025-12 NCT04001777

     APG-1252osimertinib FDA EU

     Cohort 3: Patients with advanced EGFR-mutated NSCLC not previously treated with TKI.

     EGFR exon 19 deletion / L858REGFR Positive Non-small Cell Lung Cancer

115. A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

     Active, not recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2018Primary completion 2027-06 NCT03567642

     osimertinib FDA EUPlatinumetoposide

     …dy of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

     EGFR exon 19 deletion / L858RLung Cancer

116. Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer

     Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2017Primary completion 2027-02 NCT02503722

     osimertinib FDA EUSapanisertib

     NSCLC must harbor an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion)

     EGFR exon 19 deletion / L858RMetastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7

117. Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor

     Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2016Primary completion 2027-06 NCT02496663

     necitumumabosimertinib FDA EU

     NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q or for EGFR Exon 20 insertion expansion cohort D, NSCLC mus…

     EGFR exon 19 deletion / L858REGFR exon 20 insertionMetastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

118. A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

     Active, not recruiting Phase 1 AbbVie Started 2014Primary completion 2026-08 NCT02099058

     osimertinib FDA EUnivolumabtelisotuzumab vedotinerlotinib FDA EU

     …ced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resi…

     EGFR exon 19 deletion / L858RAdvanced Solid Tumors Cancer

119. AZD9291 in Combination With Ascending Doses of Novel Therapeutics

     Active, not recruiting Phase 1 AstraZeneca Started 2014Primary completion 2020-03 NCT02143466

     osimertinib FDA EUsavolitinibselumetinibdurvalumab

     …our harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including exon 19 deletion and L858R).

     EGFR exon 19 deletion / L858RAdvanced Non Small Cell Lung Cancer

120. Therapy for Advanced NSCLC With EGFR 19delins Mutation

     Not yet recruiting Early Phase 1 Fuzhou General Hospital Started 2026Primary completion 2030-10 NCT07458919

     icotinibgefitinib FDA EUbefotertinibosimertinib FDA EUfurmonertinib

     Epidermal growth factor receptor (EGFR) exon 19 deletion-insertion mutation (19delins) documented by testing of tumor tissue or plasma samples usi…

     EGFR exon 19 deletion / L858RLung Cancer

121. CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC

     Not yet recruiting Early Phase 1 Second Affiliated Hospital of Nanchang University Started 2024Primary completion 2027-06 NCT06557096

     osimertinib FDA EUbevacizumab

     …tissue samples or blood samples are confirmed to have EGFR-sensitive mutations (including exon 19 deletions or L858R).

     EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-08-16Non Small Cell Lung Cancer, Circulating Tumor Cell, EGF-R Positive Non-Small Cell Lung Cancer

122. Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer

     Recruiting No phase Guangzhou Medical University Started 2024Primary completion 2026-06 NCT06304441

     osimertinib FDA EUpemetrexed

     …ytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del).

     EGFR exon 19 deletion / L858RLeptomeningeal Metastasis

123. Whole Genomic Landscape of Advanced EGFR-mutant NSCLC

     Active, not recruiting No phase Seoul National University Hospital Started 2019Primary completion 2026-09 NCT03969823

     osimertinib FDA EU

     …diotherapy with local confirmation of the presence of EGFR TKI-sensitizing mutation (EGFR exon 19 deletion or L858R mutation), either alone or in combination with other EGFR mutations excluding EG…

     EGFR exon 19 deletion / L858RLocally Advanced or Metastatic NSCLC

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