NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Amivantamab	Amivantamab will be administered.
DRUG	Lazertinib	Lazertinib tablet will be administered.
DRUG	Chemotherapy: Pemetrexed	Pemetrexed will be administered.
DRUG	Chemotherapy: Carboplatin	Carboplatin will be administered.

Timeline

• Start date: 2024-12-16
• Primary completion: 2029-05-23
• Completion: 2030-12-26
• First posted: 2024-10-31
• Last updated: 2026-04-13

Locations

196 sites across 13 countries: United States, Belgium, Finland, France, Germany, Greece, Israel, Italy, Poland, Portugal, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study