lazertinib

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 lazertinib.

1. Johnson & Johnson 9
2. Abion 1

Trials

16 of 28 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. 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

5. Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment

   Recruiting Phase 2 Sehhoon Park Started 2024Primary completion 2029-09 NCT06106802

   lazertinib FDA EUtepotinib

   Confirmed EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial re…

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

6. 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

7. 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

8. 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

9. A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker

   Recruiting Phase 2 National Cancer Center, Korea Started 2023Primary completion 2026-09 NCT06156527

   lazertinib FDA EUbevacizumab

   Patients with institutionalized EGFR mutation (exon 19 deletion or L858R)

   EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-12-05Lazertinib

10. 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

11. To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation

    Recruiting Phase 2 Abion Started 2023Primary completion 2029-02 NCT05541822

    Vabametkiblazertinib FDA EU

    EGFR mutation-positive including exon 19 deletions or exon 21 L858R as detected by an FDA-approved or other validated test in a CLIA certif…

    EGFR exon 19 deletion / L858RMET exon 14 skippingAdvanced Solid Tumors

12. Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer

    Active, not recruiting Phase 2 Yonsei University Started 2022Primary completion 2028-05 NCT06268210

    lazertinib FDA EUpemetrexedcarboplatin

    Documented presence of EGFR activating mutations (EGFR exon 19 deletion or L858R mutation).

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

13. Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy

    Recruiting Phase 2 Konkuk University Medical Center Started 2022Primary completion 2024-05 NCT05469022

    lazertinib FDA EU

    …th the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2022-07-21Non Small Cell Lung Cancer

14. 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

15. 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

16. 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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