Study Comparing Sacituzumab Tirumotecan to Chemotherapy in Previously Treated Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer with EGFR Mutations or Other Genetic Changes
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06074588
This clinical trial is testing a new drug, sacituzumab tirumotecan, against standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations. The study aims to see if the new drug can help patients live longer without the cancer getting worse.
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Program Overview
The study is investigating whether sacituzumab tirumotecan is more effective than standard chemotherapy (docetaxel or pemetrexed) for treating advanced non-small cell lung cancer (NSCLC) in patients who have specific genetic mutations, such as EGFR mutations or other genomic changes. The main goals are to see if the new drug can help patients live longer without the cancer progressing and improve overall survival compared to chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with specific genetic mutations.
- Cancer must have worsened after previous treatment, as shown by medical imaging.
- Have received 1 or 2 previous treatments with specific cancer drugs, including a third-generation drug for certain mutations, and one platinum-based chemotherapy after the cancer worsened.
- Have measurable cancer that can be tracked by scans.
- Provide a tumor sample from a biopsy.
- Have recovered from side effects of previous cancer treatments to a mild level or baseline.
- If positive for hepatitis B, must have been treated with antiviral therapy and have no detectable virus.
- If HIV-positive, must have well-controlled HIV with medication.
- Be in good overall health with a performance status score of 0 or 1.
Exclusion Criteria
- Have a type of lung cancer called squamous cell NSCLC.
- Have tumors with small cell elements.
- Have active inflammatory bowel disease or a history of it.
- Have moderate to severe nerve damage.
- Have severe eye conditions that affect healing.
- Have uncontrolled heart or blood vessel disease.
- Have a specific EGFR mutation and have not received a third-generation drug for it.
- Have had cancer treatment or experimental drugs recently.
- Have had a live vaccine recently.
- Have had recent radiation therapy or have not recovered from its side effects.
- Have had certain types of previous cancer treatments.
- Have another active cancer that needed treatment in the last 3 years.
- Have an active infection needing treatment.
- Have lung inflammation that needed steroids or currently have it.
- Have untreated or unstable brain cancer spread.
- Have HIV with certain complications.
- Have active hepatitis B or C infections.
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