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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 25, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT02609776). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 751 participants (ACTUAL). Conditions: Non-Small-Cell Lung Cancer. Interventions: DRUG: Amivantamab; DRUG: Amivantamab; DRUG: Lazertinib; DRUG: Carboplatin; DRUG: Pemetrexed. Primary outcome measures: Part 1: Number of Participants With Dose Limiting Toxicity (DLT) , Up to Day 28; Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs , Screening up to follow-up (30 [+7] days after the last dose); Part 2: Overall Response Rate (ORR) , Up to End of Treatment Follow (EOT) Up Period (30 [+7] days after the last dose); Part 2: Duration of Response (DOR) , Up to EOT Follow Up Period (30 [+7] days after the last dose); Part 2: Percentage of Participants With Clinical Benefit , Up to EOT Follow Up Period (30 [+7] days after the last dose); Trough Serum Concentration (Ctrough) of Amivantamab , Up to EOT (30 days after last dose); Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab , Up to EOT (30 days after last dose). Brief summary: The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).