Study on Sacituzumab Tirumotecan and Pembrolizumab Combination Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer with High PD-L1 Levels

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06170788

This clinical trial is comparing the effectiveness of a new drug combination, sacituzumab tirumotecan with pembrolizumab, against pembrolizumab alone in treating metastatic non-small cell lung cancer (NSCLC) with high levels of PD-L1. The study aims to see if the combination improves overall survival compared to pembrolizumab alone.

Patient Parameters

Program Overview

The main goal of this study is to find out if combining sacituzumab tirumotecan with pembrolizumab can help patients with metastatic non-small cell lung cancer (NSCLC) live longer compared to using pembrolizumab alone. Participants who have completed the initial treatment with pembrolizumab may be eligible for additional cycles if their cancer progresses, as confirmed by an independent review.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC) that is either squamous or non-squamous.
  • Not suitable for treatments targeting EGFR, ALK, or ROS1 mutations.
  • Tumor shows PD-L1 expression in 50% or more of cells.
  • Good overall health with a performance status of 0 or 1.
  • Expected to live at least 3 more months.
  • If HIV-positive, must have well-controlled HIV on antiretroviral therapy.

Exclusion Criteria

  • Diagnosed with small cell lung cancer or mixed tumors with small cell elements.
  • Have significant nerve damage (Grade 2 or higher).
  • Have severe eye conditions that affect healing.
  • Have active inflammatory bowel disease or a history of it.
  • Have uncontrolled heart or blood vessel disease within the last 6 months.
  • Have received previous systemic cancer treatment for metastatic NSCLC.
  • Have had prior treatment with certain immune therapies unless completed over a year ago for non-metastatic NSCLC.
  • Have had recent cancer treatments or radiation therapy to the lung exceeding 30 Gy within 6 months.
  • Have received a live vaccine within 30 days before starting the study.
  • Have an immune deficiency or are on long-term steroid therapy.
  • Have another progressing cancer or one treated in the last 3 years.
  • Have active brain metastases or cancer in the brain lining.
  • Have allergies to the study drugs or their components.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • Have active Hepatitis B or C infections.
  • Have HIV with a history of certain related diseases.
  • Have had a tissue or organ transplant.
  • Need treatment with certain strong medications affecting liver enzymes.

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