marked.bio

EGFR TKI (3rd generation) · small molecule

furmonertinib

36 active trials across 3 of our biomarkers, targeting EGFR. Not approved for any biomarker on marked.bio yet.

Also known as firmonertinib, alflutinib, AST2818, Ivesa.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 34 53 Phase 4
EGFR exon 20 insertion 3 5 Phase 3
HER2 (ERBB2) activating mutation 1 2 Phase 1

Sponsors

Industry sponsors leading active biomarker-selected trials of furmonertinib.

  1. Allist Pharmaceuticals 4
  2. ArriVent BioPharma 2
  3. RemeGen 1
  4. Abbisko Therapeutics 1
  5. InxMed 1

Trials

36 of 57 trials shown

  1. Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases

    Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Started 2025Primary completion 2027-05 NCT07092202

    furmonertinibpemetrexed

    …ed by histological or cytological specimens tested in the central laboratory to have EGFR exon 19 deletion mutation (19DEL) or exon 21 L858R point mutation (L858R), which can exist alone or in com…

    EGFR exon 19 deletion / L858RLeptomeningeal Metastasis, NSCLC, Intrathecal Chemotherapy, Tyrosine Kinase Inhibitor

  2. 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

  3. Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations

    Recruiting Phase 3 Peking Union Medical College Hospital Started 2024Primary completion 2026-12 NCT06674343

    furmonertinib

    …ents have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)

    EGFR exon 19 deletion / L858RAdvanced or Metastatic Non-small Cell Lung Cancer

  4. Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

    Active, not recruiting Phase 3 ArriVent BioPharma Started 2023Primary completion 2025-08 NCT05607550

    furmonertinibplatinum-based chemotherapy

    Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.

    EGFR exon 20 insertionMetastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations

  5. To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

    Recruiting Phase 3 Allist Pharmaceuticals Started 2021Primary completion 2026-12 NCT04853342

    furmonertinib

    …bors 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 / L858RNon-small Cell Lung Carcinoma

  6. Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）

    Active, not recruiting Phase 3 Allist Pharmaceuticals Started 2019Primary completion 2021-09 NCT03787992

    furmonertinibgefitinib FDA EU

    …ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

    EGFR exon 19 deletion / L858RLocally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer

  7. A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2028-01 NCT07548060

    sacituzumab tirumotecanfurmonertinib

    …er (AJCC)\], with tissue or blood-based genetic testing showing EGFR-sensitive mutations (19del and L858R).

    EGFR exon 19 deletion / L858RNSCLC Stage IV, EGFR Gene Mutation

  8. Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression

    Recruiting Phase 1/2 Second Affiliated Hospital of Nanchang University Started 2026Primary completion 2027-12 NCT07655622

    vebreltinibfurmonertinib

    …ed/metastatic disease Histologically or cytologically confirmed EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R point mutation)

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

  9. Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg

    Not yet recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2026Primary completion 2030-12 NCT07298148

    furmonertinib

    Documented EGFR 19del or L858R mutation.

    EGFR exon 19 deletion / L858RNSCLC Stage IV, EGFR Positive Non-small Cell Lung Cancer, EGFR-TKI Sensitizing Mutation

  10. Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

    Recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2026Primary completion 2029-12 NCT07622706

    furmonertinib

    5.EGFR mutation-positive (19Del and/or L858R, with or without T790M) as determined by NGS testing of tumor tissue or bloo…

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

  11. Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

    Not yet recruiting Phase 2 Jiangmen Central Hospital Started 2026Primary completion 2027-10 NCT07482605

    furmonertinib

    Positive for EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R).

    EGFR exon 19 deletion / L858RLung Cancer (NSCLC), Malignant Pleural Effusions (Mpe)- Pleurodesis

  12. A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer

    Not yet recruiting Phase 2 Anhui Provincial Cancer Hospital Started 2026Primary completion 2029-03 NCT07661173

    furmonertinibpemetrexedcarboplatinbevacizumab

    Confirmed presence of EGFR mutation-positive by tumor histology, cytology, or hematology;

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

  13. Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study

    Not yet recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2026-05 NCT07365410

    furmonertinibcarboplatinpemetrexed

    Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer (NSCLC), Brain Metastases, Furmonertinib, EGFR Mutation

  14. Neoadjuvant Therapy With Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy for Resectable EGFR-Mutated NSCLC

    Not yet recruiting Phase 2 Hubei Cancer Hospital Started 2026Primary completion 2028-03 NCT07807722

    furmonertinibanlotinib

    EGFR mutation positive non-small cell lung cancer (including 19Del and 21L858R) confirmed by biopsy

    EGFR exon 19 deletion / L858RNSCLC (Non-small Cell Lung Cancer), EGFR, Neoadjuvant Therapy

  15. Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure

    Recruiting Phase 1/2 Peking University Cancer Hospital & Institute Started 2025Primary completion 2027-04 NCT07087223

    vebreltinibfurmonertinib

    Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation).

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer NSCLC

  16. Firmonertinib Combined With Chemotherapy as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC

    Not yet recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2025Primary completion 2026-12 NCT06890182

    furmonertinibcarboplatincisplatinpemetrexed

    EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  17. Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2025Primary completion 2028-12 NCT07304739

    furmonertinibIntrathecal chemotherapy

    … patient was confirmed by a local laboratory to have one of the following EGFR mutations :19Del or L858R;

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

  18. Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

    Not yet recruiting Phase 2 Fudan University Started 2025Primary completion 2026-07 NCT07193160

    sacituzumab tirumotecanfurmonertinib

    …ious EGFR mutation test results (known presence of EGFR mutations sensitive to EGFR-TKI \[Ex19del, L858R\], which may exist alone or concurrently with other EGFR mutations, possibly inclu…

    EGFR exon 19 deletion / L858RNSCLC (Non-small Cell Lung Cancer)

  19. A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

    Recruiting Phase 2 RemeGen Started 2025Primary completion 2026-05 NCT06962865

    RC108furmonertinib

    Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity;

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  20. High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC

    Not yet recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2025Primary completion 2029-12 NCT07182708

    furmonertinibbevacizumab

    EGFR mutation-positive confirmed by local laboratory testing of tissue or blood samples.

    EGFR exon 19 deletion / L858RNSCLC (Non-small Cell Lung Cancer), EGFR Activating Mutation, Resectable Lung Non-Small Cell Carcinoma

  21. 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

  22. A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib

    Recruiting Phase 2 Abbisko Therapeutics Started 2024Primary completion 2027-12 NCT06668103

    furmonertinib

    Documented genetic testing reports confirmed the presence of EGFR L858R or EGFR exon 19 del mutations in tumor or plasma ctDNA.

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

  23. High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI

    Recruiting Phase 2 Jialei Wang Started 2024Primary completion 2026-12 NCT06652048

    furmonertinib

    High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  24. A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC

    Not yet recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2024Primary completion 2025-11 NCT06585644

    furmonertinib

    Inclusion Criteria: 1) EGFR mutation-positive (including 19Del and 21L858R) non-small cell lung cancer (NSCLC) confirmed by biopsy

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-09-05Lung Cancer (NSCLC)

  25. Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases

    Not yet recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2024Primary completion 2025-12 NCT06483672

    furmonertinibanlotinib

    Tumor tissue samples or blood samples are confirmed to be EGFR mutations;

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-07-03Adenocarcinoma of Lung Metastatic to Brain

  26. 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

  27. Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)

    Active, not recruiting Phase 2 Tang-Du Hospital Started 2023Primary completion 2025-09 NCT05430802

    furmonertinibpemetrexed

    EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  28. Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC

    Recruiting Phase 2 Shanghai Zhongshan Hospital Started 2023Primary completion 2028-08 NCT05987826

    furmonertinib

    7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  29. IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC

    Recruiting Phase 1/2 InxMed Started 2023Primary completion 2026-07 NCT05994131

    ifebemtinibfurmonertinib

    Documented EGFR mutations known to be associated with EGFR-TKI sensitivity, including Ex19del or L858R.

    EGFR exon 19 deletion / L858RNSCLC

  30. Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA

    Recruiting Phase 2 Sun Yat-sen University Started 2022Primary completion 2025-02 NCT05334277

    furmonertinibpemetrexedcarboplatinbevacizumab

    Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically and confirmed by ctDNA, the r…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2022-08-31Non-small Cell Lung Cancer

  31. Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma

    Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2022Primary completion 2023-10 NCT05503667

    furmonertinibbevacizumab

    …umab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2022-08-17Lung Adenocarcinoma Stage III, Lung Adenocarcinoma Stage IV, EGFR Gene Mutation

  32. Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion

    Active, not recruiting Phase 2 Allist Pharmaceuticals Started 2022Primary completion 2025-06 NCT05466149

    furmonertinib

    …as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation

    EGFR exon 20 insertionNSCLC

  33. Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

    Active, not recruiting Phase 1 ArriVent BioPharma Started 2022Primary completion 2025-06 NCT05364073

    furmonertinib

    … results from local testing of either tumor tissue or blood confirming the presence of an EGFR activating mutation, performed at a CLIA- or equivalently certified laboratory.

    EGFR exon 19 deletion / L858REGFR exon 20 insertionHER2 (ERBB2) activating mutationNon-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations

  34. 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

  35. Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis

    Recruiting No phase Guangzhou University of Traditional Chinese Medicine Started 2026Primary completion 2028-09 NCT07348965

    furmonertinib

    Patients with EGFR exon 19 deletion or exon 21 L858R mutation

    EGFR exon 19 deletion / L858RNSCLC (Advanced Non-small Cell Lung Cancer), Leptomeningeal Metastasis, Furmonertinib, EGFR Activating Mutation

  36. Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis

    Recruiting No phase Henan Cancer Hospital Started 2024Primary completion 2025-03 NCT06643000

    furmonertinibbevacizumabpemetrexed

    Genetic testing confirming positive for classical or non-classical EGFR mutations;

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, Leptomeningeal Metastasis, EGFR Gene Mutation