Study Comparing Sacituzumab Tirumotecan with Pemetrexed and Carboplatin for Advanced Non-Small Cell Lung Cancer with EGFR Mutation

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06305754

Provider View

This clinical trial is testing whether sacituzumab tirumotecan is more effective than the combination of pemetrexed and carboplatin in treating advanced non-small cell lung cancer (NSCLC) with an EGFR mutation that has worsened after previous treatments.

Patient Parameters

Program Overview

The aim of this study is to compare two treatments for advanced non-squamous non-small cell lung cancer (NSCLC) that has a specific mutation in the epidermal growth factor receptor (EGFR) and has not improved with previous EGFR-targeted therapies. The study will test if sacituzumab tirumotecan can help patients live longer without the cancer getting worse, compared to the standard chemotherapy combination of pemetrexed and carboplatin.

Description

Participants in this study will be randomly assigned to one of two treatment groups:

  • One group will receive sacituzumab tirumotecan.
  • The other group will receive a combination of pemetrexed and carboplatin.

Participants will continue their assigned treatment until they meet specific criteria for stopping the study treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer (NSCLC).
  • Have recovered from side effects of previous cancer treatments to a mild level or back to normal.
  • If positive for Hepatitis B, must have been on antiviral therapy for at least 4 weeks with no detectable virus.
  • If previously infected with Hepatitis C, must have no detectable virus.
  • If HIV-positive, must have well-controlled HIV with medication.
  • Have a life expectancy of at least 3 months.

Exclusion Criteria

  • Have a type of lung cancer called squamous cell NSCLC.
  • Have had another cancer unless treated successfully with no return for 3 years.
  • Have severe nerve damage.
  • Have severe eye conditions that affect healing.
  • Have active inflammatory bowel disease needing medication or a history of it.
  • Have serious heart or blood vessel disease.
  • Have had recent radiation therapy or side effects needing steroids.
  • Have had a live vaccine within 30 days before starting the study.
  • Have had high-dose lung radiation recently.
  • Have active cancer spread to the brain or spinal fluid.
  • Have an active infection needing treatment.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have HIV with a history of certain related diseases.
  • Have both active Hepatitis B and C infections.
  • Have had a tissue or organ transplant.
  • Have not fully recovered from major surgery or have ongoing surgical issues.

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