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.
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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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