Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04988295 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
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
NotableLead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLCCompletion pushed from Nov 30, 2027 to Jul 3, 2028 · Eligibility criteria expanded, about 13 words · Study sites revised (249)Show 3 more changesShow less
Completion pushed from Nov 30, 2027 to Jul 3, 2028
Eligibility criteria expanded, about 13 words
Study sites revised (249)
MinorCompletion moved earlier from Mar 1, 2028 to Nov 30, 2027Completion pushed from Nov 30, 2027 to Mar 1, 2028v62Show 1 more changeShow less
Completion pushed from Nov 30, 2027 to Mar 1, 2028
MinorCompletion date: Nov 30, 2027 to Mar 1, 2028v61
MinorCompletion date: Jun 30, 2026 to Sep 30, 2026Secondary endpoints shortened, about 120 words · Study sites revised (247)v41Show 2 more changesShow less
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 690 to confirmed 776 · Study sites: 246 to 248 · Primary completion date changed from estimate of May 31, 2023 to Jul 10, 2023v26Show 3 more changesShow less
Enrollment target: estimated 690 to confirmed 776
Study sites: 246 to 248
Primary completion date changed from estimate of May 31, 2023 to Jul 10, 2023
MinorStudy sites: 244 to 246Completion date: Dec 29, 2026 to Dec 7, 2025v25Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.