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
Summary
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Timeline
- Start
- 2021-11-17
- Primary completion
- 2023-07-10
- Completion
- 2028-07-03
Outcome
Met primary endpoint
registry Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) vs Main Study: Arm B: Carboplatin + Pemetrexed (CP); p <0.0001 NCT04988295 ↗
registry p <0.0001; Hazard Ratio (HR) 0.44 (95% CI 0.35 to 0.56) NCT04988295 ↗
release “Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival” jnj.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amivantamab | Monoclonal antibody | — | Intravenous |
| Subject | Lazertinib | Small molecule | — | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |