AstraZeneca

Biomarkers

• EGFR exon 19 deletion / L858R13
• BRCA1/2 mutation10
• Claudin 18.2 expression7
• HER2-low / ultralow (IHC 1+ or 2+/ISH-)5
• HER2 (ERBB2) activating mutation3
• KRAS G12D1
• PIK3CA activating mutation1
• IDH1/2 mutation1
• NPM1 mutation1
• ESR1 mutation1
• MET exon 14 skipping1
• FGFR3 alteration (mutation or fusion)1
• MSI-H / dMMR1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

osimertinib 19trastuzumab deruxtecan 9durvalumab 9datopotamab deruxtecan 7olaparib 7AZD0901 5savolitinib 5saruparib 3capivasertib 3fulvestrant 3anastrozole 3pembrolizumab 3selumetinib 3abiraterone 2camizestrant 2abemaciclib 2ribociclib 2palbociclib 2letrozole 2oleclumab 2

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

• 2026-10 Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients Phase 3 · PIK3CA activating mutation
• 2026-11 AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 Phase 2 · Claudin 18.2 expression
• 2027-01 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 Phase 3 · EGFR exon 19 deletion / L858R
• 2027-01 Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC Phase 2 · MET exon 14 skipping
• 2027-03 Study for AZD4360 in Participants With Advanced Solid Tumours Phase 1/2 · Claudin 18.2 expression
• 2027-05 Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) Phase 2 · HER2-low / ultralow (IHC 1+ or 2+/ISH-)
• 2027-08 A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection Phase 3 · EGFR exon 19 deletion / L858R
• 2027-10 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 Phase 2 · EGFR exon 19 deletion / L858R

Trials

54 of 100 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. An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.

   Recruiting Phase 4 AstraZeneca Started 2026Primary completion 2028-01 NCT07357597

   dexamethasonedatopotamab deruxtecan FDA

   Patients with locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy.

   EGFR exon 19 deletion / L858RStomatitis

3. Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

   Active, not recruiting Phase 4 AstraZeneca Started 2022Primary completion 2024-10 NCT05457257

   olaparib FDA EUenzalutamide FDAabiraterone FDA EUprednisone

   Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.

   BRCA1/2 mutationMetastatic Castration-resistant Prostate Cancer

4. Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

   Recruiting Phase 3 AstraZeneca Started 2026Primary completion 2029-08 NCT07431281

   AZD0901Rilvegostomignivolumabcapecitabinefluorouraciloxaliplatinzolbetuximab FDA EUleucovorin

   Positive CLDN18.2 expression, as determined prospectively by central IHC testing

   Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

5. A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

   Recruiting Phase 3 AstraZeneca Started 2025Primary completion 2033-03 NCT06952803

   saruparibabiraterone FDA EUprednisoneAndrogen Deprivation Therapy (ADT)

   …uparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

   BRCA1/2 mutationProstate Cancer

6. 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

7. 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

8. Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients

   Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-10 NCT06635447

   capivasertib FDA EUfulvestrant FDA EU

   Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients en…

   PIK3CA activating mutationBreast Cancer

9. Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

   Recruiting Phase 3 AstraZeneca Started 2024Primary completion 2029-12 NCT06380751

   saruparibcamizestrantabemaciclibribociclibpalbociclibfulvestrantletrozoleanastrozoleExemestane

   Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2

   BRCA1/2 mutationAdvanced Breast Cancer

10. AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-05 NCT06346392

    AZD0901ramucirumabpaclitaxeldocetaxelirinotecantrifluridine/tipiracilapatinib

    (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer

11. 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

12. 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

13. 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

14. A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2026-06 NCT05048797

    trastuzumab deruxtecan FDA EUcisplatincarboplatinpembrolizumabpemetrexed

    Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA

    HER2 (ERBB2) activating mutationLocally Advanced or Metastatic Non-Small Cell Lung Cancer

15. Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2025-06 NCT04964934

    camizestrant FDAanastrozoleletrozolepalbociclibabemaciclib FDALuteinizing hormone-releasing hormone (LHRH) agonistribociclib

    Have an ESR1 mutation in their cancer;

    ESR1 mutationER-Positive HER2-Negative Breast Cancer

16. 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

17. Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2020Primary completion 2024-03 NCT04494425

    trastuzumab deruxtecan FDA EUcapecitabinepaclitaxelnab-paclitaxel

    3. has HER2-low or HER2 IHC \>0 \<1+ expression as determined by the central laboratory result establishe…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced or Metastatic Breast Cancer

18. 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

19. 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)

20. 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

21. Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2014Primary completion 2020-03 NCT02032823

    olaparib FDA EU

    Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    BRCA1/2 mutationBreast Cancer

22. Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

    Active, not recruiting Phase 3 AstraZeneca Started 2013Primary completion 2016-06 NCT01933932

    selumetinibdocetaxelpegfilgrastim

    KRAS mutation positive tumour sample as determined by the designated testing laboratory

    KRAS G12CKRAS G12DLocally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

23. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

    Active, not recruiting Phase 3 AstraZeneca Started 2013Primary completion 2016-09 NCT01874353

    olaparib FDA EU

    Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    BRCA1/2 mutationPlatinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy

24. Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

    Active, not recruiting Phase 3 AstraZeneca Started 2013Primary completion 2018-05 NCT01844986

    olaparib FDA EU

    … with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer an…

    BRCA1/2 mutationNewly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA Mutation

25. 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

26. Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

    Recruiting Phase 1/2 AstraZeneca Started 2026Primary completion 2029-02 NCT07155226

    AZD3632Posaconazole

    b) for Backfill - diagnosis of harbouring a KMT2Ar or NPM1m per local testing.

    NPM1 mutationAcute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia, Higher-risk Myelodysplastic Syndromes

27. A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

    Recruiting Phase 2 AstraZeneca Started 2025Primary completion 2027-11 NCT07069712

    AZD0901Rilvegostomigtrastuzumab deruxtecancapecitabinefluorouracilFLOT Chemotherapyleucovorin

    Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2

    Claudin 18.2 expressionGastroesophageal Adenocarcinoma

28. Study for AZD4360 in Participants With Advanced Solid Tumours

    Active, not recruiting Phase 1/2 AstraZeneca Started 2025Primary completion 2027-03 NCT06921928

    AZD4360

    …phageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma

29. A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

    Active, not recruiting Phase 2 AstraZeneca Started 2025Primary completion 2026-08 NCT07143604

    AZD0901

    …advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer

30. 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

31. A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors

    Recruiting Phase 1/2 AstraZeneca Started 2024Primary completion 2028-12 NCT06130553

    AZD3470datopotamab deruxtecan FDA

    …defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced/metastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligi…

    EGFR exon 19 deletion / L858RAdvanced Solid Tumors That Are MTAP Deficient

32. A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

    Active, not recruiting Phase 2 AstraZeneca Started 2024Primary completion 2026-10 NCT06008093

    durvalumabtremelimumabpemetrexedpembrolizumabcarboplatincisplatin

    Participants must have tumors with STK11 or KEAP1 or KRAS mutations.

    KRAS G12CKRAS G12DCarcinoma, Non-Small-Cell Lung

33. 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

34. 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)

35. Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1/2 AstraZeneca Started 2023Primary completion 2029-03 NCT06005493

    AZD5863AZD2936

    Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)

    Claudin 18.2 expressionGastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma

36. AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

    Recruiting Phase 2 AstraZeneca Started 2023Primary completion 2026-11 NCT06219941

    AZD0901fluorouracilleucovorinirinotecanliposomal irinotecangemcitabine

    Participants who are CLDN18.2 positive.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma

37. A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

    Active, not recruiting Phase 2 AstraZeneca Started 2022Primary completion 2024-11 NCT05246514

    trastuzumab deruxtecan FDA EU

    …Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

    HER2 (ERBB2) activating mutationHER2-mutant Non-Small Cell Lung Cancer

38. Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 AstraZeneca Started 2022Primary completion 2028-02 NCT05417594

    AZD9574temozolomide[11C]AZ1419 3391trastuzumab deruxtecandatopotamab deruxtecan

    …ced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D,

    BRCA1/2 mutationIDH1/2 mutationHER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Solid Malignancies

39. Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC

    Active, not recruiting Phase 2 AstraZeneca Started 2022Primary completion 2027-01 NCT05374603

    savolitinibdurvalumab

    MET Exon 14 skipping mutation, or MET overexpression (IHC 3+ in ≥70% of tumor cells), or MET amplific…

    MET exon 14 skippingLung Cancer

40. A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

    Active, not recruiting Phase 1/2 AstraZeneca Started 2022Primary completion 2023-11 NCT05460273

    datopotamab deruxtecan

    …ted positive test results for one or more actionable genomic alteration: EGFR, ALK, ROS1, METex14 skipping, RET or other AGAs with approved therapies

    MET exon 14 skippingCarcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer

41. 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

42. A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

    Active, not recruiting Phase 2 AstraZeneca Started 2020Primary completion 2023-01 NCT04639219

    trastuzumab deruxtecan FDA EU

    Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772\_A775dup / A775\_G776insYVMA, L755…

    HER2 (ERBB2) activating mutationAdvanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

43. Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

    Active, not recruiting Phase 2 AstraZeneca Started 2020Primary completion 2027-05 NCT04379596

    fluorouracilcapecitabinedurvalumaboxaliplatintrastuzumabtrastuzumab deruxtecan FDA EUcisplatinpembrolizumabVolrustomigRilvegostomig

    … 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Gastric Cancer

44. 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

45. 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

46. A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

    Active, not recruiting Phase 1/2 AstraZeneca Started 2018Primary completion 2024-11 NCT03742102

    durvalumabcapivasertiboleclumabpaclitaxeltrastuzumab deruxtecan FDA EUdatopotamab deruxtecan

    …provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Triple Negative Breast Neoplasms

47. A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

    Active, not recruiting Phase 1/2 AstraZeneca Started 2016Primary completion 2021-09 NCT02734004

    olaparib FDA EUdurvalumabbevacizumab FDA EU

    gBRCAm HER2-negative metastatic breast cancer (module 2)

    BRCA1/2 mutationOvarian, Breast, SCLC, Gastric Cancers

48. A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

    Recruiting Phase 1 AstraZeneca Started 2025Primary completion 2029-04 NCT06879041

    AZD2287AZD2275AZD2284

    b)A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation

    BRCA1/2 mutationMSI-H / dMMRMetastatic Castration-Resistant Prostate Cancer

49. Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

    Recruiting Phase 1 AstraZeneca Started 2024Primary completion 2027-08 NCT06218914

    NT-112: Autologous, engineered T Cells targeting KRAS G12DAZD0240: Autologous, engineered T Cells targeting KRAS G12D

    Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

    KRAS G12CKRAS G12DNon-small Cell Lung Cancer, Colorectal Carcinoma, Pancreatic Ductal Adenocarcinoma, Endometrial Cancer

50. 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

51. A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2020Primary completion 2023-08 NCT04556773

    trastuzumab deruxtecan FDA EUdurvalumabpaclitaxelcapivasertibanastrozolefulvestrantcapecitabine

    Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer

52. Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2016Primary completion 2020-03 NCT02546661

    fexagratinibdurvalumabolaparibadavosertibVistusertibAZD9150selumetinib

    Confirmation of FGFR3 mutation or FGFR fusion

    FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementMuscle Invasive Bladder Cancer

53. 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

54. Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

    Active, not recruiting Phase 1 AstraZeneca Started 2014Primary completion 2025-03 NCT02264678

    ceralasertibolaparib FDA EUdurvalumabsaruparibcarboplatin

    Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status

    BRCA1/2 mutationAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer

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