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)

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 tablet will be administered.
• Chemotherapy: Pemetrexed — DRUG
  Pemetrexed will be administered.
• Chemotherapy: Carboplatin — DRUG
  Carboplatin will be administered.

Study Details

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).

Key Dates

Start date

Dec 16, 2024

Status verified

Jun 2026

Primary completion

May 23, 2029

Completion

Dec 26, 2030

Study Design

Enrollment

480 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Amivantamab and Lazertinib
  Participants will receive Amivantamab in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.
• Experimental: Cohort 2: Amivantamab and Chemotherapy
  Participants will receive Amivantamab in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 4 Years and 6 months ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (150)

Find similar trials in Daphne, AL

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