Study on Pembrolizumab With or Without Sacituzumab Tirumotecan for Treating Non-Small Cell Lung Cancer After Surgery

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06312137

This clinical trial is testing whether adding sacituzumab tirumotecan to pembrolizumab after surgery can improve treatment outcomes for adults with non-small cell lung cancer (NSCLC) who did not achieve a complete response from surgery alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining sacituzumab tirumotecan with pembrolizumab after surgery is more effective than using pembrolizumab alone in treating non-small cell lung cancer (NSCLC) that has not been completely removed by surgery. The study will compare how long patients remain free of cancer when treated with the combination versus pembrolizumab alone.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with a specific type of non-small cell lung cancer (NSCLC) that can be surgically removed and is at Stage II, IIIA, or IIIB with certain lymph node involvement.
  • Confirmed that treatment targeting the EGFR gene is not suitable as the main therapy.
  • Able to undergo surgery as determined by the doctor and surgeon.
  • Can receive pembrolizumab and a specific type of chemotherapy before surgery.
  • After surgery, the cancer was not completely removed, as confirmed by a local pathology review.
  • Tumor tissue from surgery must be available for testing specific markers before starting the next phase of treatment.
  • Confirmed to be free of disease based on recent imaging tests before starting the next phase of treatment.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to baseline.
  • HIV-positive participants must have well-controlled HIV with medication.
  • Participants with hepatitis B must have been treated for at least 4 weeks and have an undetectable viral load.
  • Participants with a history of hepatitis C must have an undetectable viral load at least 4 weeks before starting the study treatment.

Exclusion Criteria

  • Have certain types of lung cancer, such as those involving the superior sulcus, large cell neuro-endocrine cancer, sarcomatoid tumor, or small cell elements.
  • Have specific genetic changes in the cancer, like ALK gene rearrangements.
  • Have moderate to severe nerve damage.
  • Have severe eye conditions that affect healing.
  • Have active inflammatory bowel disease needing medication or a history of it.
  • Have uncontrolled heart or blood vessel diseases, including severe heart failure, recent heart attack, or serious heart rhythm problems.
  • Have received prior treatment for the current lung cancer diagnosis.
  • Have had cancer treatments, including experimental drugs, within 4 weeks before starting the study.
  • Have had radiation therapy within 2 weeks before starting the study or have side effects from it needing steroids.
  • Have received a live vaccine within 30 days before starting the study.
  • Have used an experimental device or drug within 4 weeks before starting the study.
  • Have an immune system deficiency or are on high-dose steroids or other immune-suppressing drugs.
  • Have another active cancer needing treatment in the past 5 years.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • Have HIV with a history of certain cancers.
  • Have active hepatitis B and C infections.
  • Have a severe allergy to sacituzumab tirumotecan or similar drugs.
  • Have had a tissue or organ transplant.
  • Have not fully recovered from major surgery or have ongoing surgical issues.

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