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
Phase 3
Active, not recruiting
NCT04988295
| Condition | Carcinoma, Non-Small-Cell Lung |
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| Phase | Phase 3 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Active, not recruiting |
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| Enrollment | 776 participants |
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| Interventions | Lazertinib, Amivantamab, Pemetrexed, Carboplatin |
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| Start date | Nov 17, 2021 |
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| Completion date | Jul 10, 2023 |
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| Results posted | Apr 16, 2025 |
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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.
Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months) · months
| Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) | 8.31 months |
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| Main Study: Arm B: Carboplatin + Pemetrexed (CP) | 4.17 months |
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| Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP) | 6.28 months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.44 (95% CI 0.35–0.56) |
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Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
up to 4 years 10 months
Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review
Up to 4 years 10 months
Open in BENITIONS
View on ClinicalTrials.gov
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