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NotableLead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLCCompletion pushed from Dec 31, 2026 to Dec 31, 2027 · Eligibility criteria expanded, about 11 wordsShow 2 more changesShow less
Completion pushed from Dec 31, 2026 to Dec 31, 2027
Eligibility criteria expanded, about 11 words
Minor9 versionsRe-verified since Oct 9, 2025, no change to tracked fieldsv108-v116
NotablePrimary and study completion dates: Dec 31, 2025 to Dec 31, 2026v107
MinorRe-verified, no change to tracked fieldsv106
NotablePrimary completion date: Jan 31, 2024 to Dec 31, 2025v105
Show 37 earlier versionsHide 37 earlier versions
MinorCompletion date: Jun 30, 2025 to Dec 31, 2025v104
Minor14 versionsRe-verified since Apr 23, 2024, no change to tracked fieldsv90-v103
MinorPrimary completion date changed from estimate of Jan 4, 2024 to Jan 31, 2024Completion date: Dec 31, 2024 to Jun 30, 2025 · Study sites revised (69)v89Show 2 more changesShow less
MinorCompletion date: Jan 30, 2024 to Dec 31, 2024v87
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 780 to confirmed 751 · Study sites: 90 to 69 · Completion date: Jan 26, 2024 to Jan 30, 2024v86Show 3 more changesShow less
MinorCompletion date: Jan 4, 2024 to Jan 26, 2024v68
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).