Study on Amivantamab for Advanced or Metastatic Solid Tumors, Including EGFR-Mutated Non-Small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05498428
This clinical trial is testing the safety and effectiveness of a new drug, amivantamab, in combination with other treatments for patients with advanced or metastatic solid tumors, including those with specific mutations in non-small cell lung cancer (NSCLC).
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Program Overview
The purpose of this study is to evaluate how well the drug amivantamab works against tumors and to assess its safety when given with other treatments. The study includes different groups of patients, some of whom will receive amivantamab with a special enzyme to help its absorption, while others will receive it as part of a combination treatment.
Eligibility Criteria
Inclusion Criteria
- Must have advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
- Specific requirements for different groups, such as having certain genetic mutations (EGFR mutations) or having previously received specific treatments.
- Must have at least one tumor that can be measured by scans.
- May have another type of cancer that does not interfere with the study.
- Must have good organ function and overall health.
- Must agree to use preventive blood thinners if required by the study.
- Women must agree not to donate eggs during the study and for six months after the last treatment.
Exclusion Criteria
- History of certain lung diseases or severe allergic reactions to the study drugs.
- Recent vaccination with live vaccines, except for flu and non-live COVID-19 vaccines.
- Taking certain medications that interfere with the study drugs.
- Active liver disease or significant heart problems.
- Uncontrolled high blood pressure or heart failure.
- Symptomatic brain metastases, unless treated and stable for at least two weeks.
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