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Amivantamab / Carcinoma, Non Small Cell Lung / Carboplatin · Phase 3 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial comparing amivantamab plus lazertinib combined with platinum-based chemotherapy against chemotherapy alone in EGFR-mutated NSCLC after osimertinib failure. No efficacy or safety results are reported in this registry record; the study is active but not recruiting and outcome data are not yet available.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Carcinoma, Non-Small-Cell Lung; age from 18 Years. Intervention: Arm A: LACP/ACP-L; Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed); Arm A2 (Extension Cohort): ACP-L; Arm C2 (Extension Cohort): ACP. Compared with: Arm B: CP (Carboplatin and Pemetrexed) — Active Comparator. n = 776. 249 sites across 29 countries.
This is a Phase 3 randomized controlled trial comparing amivantamab plus lazertinib combined with platinum-based chemotherapy against chemotherapy alone in EGFR-mutated NSCLC after osimertinib failure. No efficacy or safety results are reported in this registry record; the study is active but not recruiting and outcome data are not yet available.
No efficacy or safety results are reported in this registry record.
Once results are published, this trial will address whether addition of lazertinib and amivantamab to platinum chemotherapy improves progression-free survival in osimertinib-resistant EGFR-mutated NSCLC. Clinicians should await peer-reviewed publication of the primary analysis.
This is a Phase 3 trial registry record with no results posted; the study is active but not recruiting, and outcomes have not yet been reported in this source.
As stated by the source record.
Quoted from the source exactly as published.
Once results are published, this trial will address whether addition of lazertinib and amivantamab to platinum chemotherapy improves progression-free survival in osimertinib-resistant EGFR-mutated NSCLC. Clinicians should await peer-reviewed publication of the primary analysis.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04988295). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 776 participants (ACTUAL). Conditions: Carcinoma, Non-Small-Cell Lung. Interventions: DRUG: Lazertinib; DRUG: Amivantamab; DRUG: Pemetrexed; DRUG: Carboplatin. Primary outcome measures: 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); 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. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.