A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07586202
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    Amivantamab will be administered.
  • Lazertinib — DRUG
    Lazertinib will be administered.
  • Carboplatin — DRUG
    Carboplatin will be administered.
  • Pemetrexed — DRUG
    Pemetrexed will be administered.

Study Details

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.

Key Dates

Start date
Jul 17, 2026
Status verified
Jun 2026
Primary completion
Mar 2, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Amivantamab plus Lazertinib
    Participants will receive amivantamab in combination with lazertinib.
  • Experimental: Cohort 2: Amivantamab plus Carboplatin and Pemetrexed
    Participants will receive amivantamab in combination with carboplatin and pemetrexed.

Primary Outcome Measure

Major Pathologic response (MPR) [ Time Frame: Up to 1 year 8 months ]

Central Contacts

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