amivantamab

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 amivantamab.

1. Johnson & Johnson 11
2. AstraZeneca 1
3. Kumquat Biosciences 1
4. ORIC Pharmaceuticals 1

Trials

23 of 26 trials shown

1. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

   Active, not recruiting Phase 3 Johnson & Johnson Started 2022Primary completion 2024-01 NCT05388669

   lazertinib FDA EUamivantamab FDA EU

   …cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by …

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

2. A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

   Active, not recruiting Phase 3 Johnson & Johnson Started 2021Primary completion 2023-07 NCT04988295

   lazertinib FDA EUamivantamab FDA EUpemetrexedcarboplatin

   …dvanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation

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

3. 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

4. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

   Active, not recruiting Phase 3 Johnson & Johnson Started 2020Primary completion 2023-05 NCT04538664

   amivantamab FDA EUpemetrexedcarboplatin

   … cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation

   EGFR exon 20 insertionCarcinoma, Non-Small-Cell Lung

5. Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study)

   Not yet recruiting Phase 2 Yonsei University Started 2026Primary completion 2031-01 NCT07507188

   amivantamab FDA EUlazertinib FDA EUcarboplatinpemetrexed

   Documented activating EGFR mutation (Exon 19 deletion or L858R)

   EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

6. Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma

   Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2026Primary completion 2028-05 NCT07744529

   amivantamab FDA EUpemetrexed

   Patients with EGFR-mutated lung adenocarcinoma with leptomeningeal metastasis diagnosed according to the EANO-ESMO g…

   EGFR exon 19 deletion / L858RLeptomeningeal Metastasis From Lung Cancer

7. Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

   Recruiting Phase 2 Fondazione Ricerca Traslazionale Started 2025Primary completion 2027-10 NCT07392658

   amivantamab FDA EU

   …ically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;

   EGFR exon 20 insertionMetastatic NSCLC - Non-Small Cell Lung Cancer

8. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

   Recruiting Phase 2 Johnson & Johnson Started 2024Primary completion 2029-05 NCT06667076

   amivantamab FDA EUlazertinib FDA EUpemetrexedcarboplatin

   …Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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

9. Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

   Active, not recruiting Phase 2 Johnson & Johnson Started 2024Primary completion 2027-05 NCT06120140

   amivantamab FDA EUlazertinib FDA EUDoxycyclineMinocyclineClindamycinChlorhexidineZinc gluconatePropranololTimololClobetasol

   Have a tumor that harbors an epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-appro…

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

10. PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2024Primary completion 2027-12 NCT06083857

    amivantamabtepotinib FDA EU

    NSCLC which harbors MET Exon 14 skipping alterations detected in the tissue or ctDNA (safety cohort and cohort A \[MET ex…

    MET exon 14 skippingNon-small Cell Lung Cancer

11. A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Johnson & Johnson Started 2023Primary completion 2027-01 NCT05908734

    Cetrelimabamivantamab FDA EU

    Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must …

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

12. Premedication to Reduce Amivantamab Associated Infusion Related Reactions

    Active, not recruiting Phase 2 Johnson & Johnson Started 2023Primary completion 2024-03 NCT05663866

    dexamethasoneMontelukastmethotrexateamivantamab FDA EUlazertinib FDA EU

    Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-ce…

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

13. 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)

14. Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI

    Active, not recruiting Phase 2 ETOP IBCSG Partners Foundation Started 2023Primary completion 2024-08 NCT05601973

    amivantamab FDA EUlazertinib FDA EUZirabev

    Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TK…

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

15. Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

    Recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2023Primary completion 2027-05 NCT05845450

    trastuzumab deruxtecandurvalumabpanitumumab FDAbotensilimabbalstilimabsotorasib FDA EUVorbipiprantnivolumabamivantamab

    COHORT 8: pMMR/MSS status and KRAS G12C mutation, absence of HER2 overexpression/amplification and wild-type status for BRAF.

    KRAS G12CMSI-H / dMMRColorectal Cancer, Resectable Colorectal Carcinoma

16. Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

    Active, not recruiting Phase 1/2 University of Colorado, Denver Started 2023Primary completion 2026-09 NCT05845671

    amivantamab

    ALK fusions - alectinib, brigatinib, lorlatinib

    ALK fusionROS1 fusionLung Cancer, Non Small Cell Lung Cancer

17. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

    Recruiting Phase 2 Johnson & Johnson Started 2022Primary completion 2027-08 NCT05498428

    amivantamab FDA EUlazertinib FDA EUcarboplatinpemetrexedDirect Oral Anticoagulant (DOAC)Low Molecular Weight Heparin (LMWH)

    …quirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation

    EGFR exon 19 deletion / L858REGFR exon 20 insertionCarcinoma, Non-small-Cell Lung

18. JIN-A02 Plus Amivantamab in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Failure

    Not yet recruiting Phase 1 Yonsei University Started 2026Primary completion 2028-06 NCT07798921

    amivantamab FDA EU

    Subjects with advanced and/or metastatic NSCLC harboring an activating EGFR mutation (Ex19del or L858R), as confirmed by testing of tissue or blood samples, whose disease has progress…

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

19. ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

    Recruiting Phase 1 ORIC Pharmaceuticals Started 2025Primary completion 2026-12 NCT06816992

    ORIC-114amivantamab FDA EU

    Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method

    EGFR exon 20 insertionSolid Tumors, EGFR Exon 20 Insertion Mutations, NSCLC, EGFR-mutated NSCLC

20. 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

21. 5G-EMERALD: Amivantamab in Malignant Brain Tumours

    Active, not recruiting Phase 1 Institute of Cancer Research, United Kingdom Started 2024Primary completion 2027-07 NCT06632236

    amivantamab

    Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2/3 are not included)

    IDH1/2 mutationMalignant Primary Gliomas, Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Glioblastoma Multiforme (GBM)

22. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2019Primary completion 2027-02 NCT04077463

    lazertinib FDA EUamivantamab FDA EUcarboplatinpemetrexed

    …Cohort D, E, and F: Participant must have advanced or metastatic EGFR-mutated NSCLC (EGFR Exon19 deletion or L858R) that has progressed on prior treatment with osimertinib in the first or second …

    EGFR exon 19 deletion / L858REGFR exon 20 insertionCarcinoma, Non-Small-Cell Lung

23. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2016Primary completion 2026-12 NCT02609776

    amivantamab FDA EUlazertinib FDA EUcarboplatinpemetrexed

    …ion Dose Escalation with lazertinib only: Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation and (a) be treatment naïve for metastatic disease, without a…

    EGFR exon 19 deletion / L858REGFR exon 20 insertionMET exon 14 skippingNon-Small-Cell Lung Cancer

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