A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Janssen Research & Development, LLC
Summary
The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy * Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test…
Interventions
- DrugAmivantamab
Amivantamab will be administered.
- DrugLazertinib
Lazertinib tablet will be administered.
- DrugChemotherapy: Pemetrexed
Pemetrexed will be administered.
- DrugChemotherapy: Carboplatin
Carboplatin will be administered.
Locations (200)
- Southern Cancer Center, PCDaphne, Alabama
- Clearview Cancer InstituteHuntsville, Alabama
- City of Hope PhoenixGoodyear, Arizona
- The Oncology Institute of Hope and InnovationCerritos, California
- City of Hope CoronaCorona, California
- City of HopeDuarte, California