A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure
A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure
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.
Inclusion Criteria:
Exclusion Criteria:
Fort Lauderdale, Florida 33308, United States
Caba, C1027AAP, Argentina
CABA, C1122, Argentina
CABA, C1414, Argentina
CABA, C1431FWO, Argentina
Córdoba, 5000, Argentina
Rio de Janeiro, 22775 001, Brazil
Ostrava- Vitkovice, 70300, Czechia
Sain-Herblain, 44800, France
New Delh, 110085, India
Gunma, 377-0280, Japan
Toon-shi, 791-0295, Japan
Poznan, 60 569, Poland
Warsaw, 02-781, Poland
Gyeongsangnam-do, 52727, South Korea