Study on Amivantamab with Lazertinib or Chemotherapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06667076

This clinical trial is testing how well the drug amivantamab works when combined with lazertinib or chemotherapy in treating patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations.

Patient Parameters

Program Overview

The main goal of this study is to evaluate the effectiveness of amivantamab, given as a subcutaneous injection, in combination with lazertinib or chemotherapy. This treatment is for patients with non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR), which is a common type of lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery aimed at curing the disease.
  • Have a specific type of EGFR mutation, either Ex19del or Ex21 L858R, confirmed by an approved test in a certified laboratory.
  • Have at least one tumor that can be measured and has not been treated with radiation.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to normal, except for hair loss, mild nerve damage, or mild thyroid issues that are stable with medication.
  • Be in good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have a history of active lung diseases like interstitial lung disease or radiation-induced lung inflammation.
  • Have had major surgery or a significant injury within four weeks before starting the study treatment, or not fully recovered from surgery, or have surgery planned during the study.
  • Have uncontrolled pain from the cancer that has not been treated with radiation.
  • Have received an experimental treatment that has not been cleared or within 12 months before starting the study treatment, or are currently in another experimental study.
  • Have another type of cancer that could interfere with the study's safety or effectiveness results.

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