Study Comparing Pembrolizumab/Vibostolimab with Chemotherapy to Pembrolizumab with Chemotherapy for Metastatic Non-Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05226598

Provider View

This clinical trial is testing whether a new combination of pembrolizumab and vibostolimab with chemotherapy is more effective than pembrolizumab with chemotherapy alone in improving survival for patients with metastatic non-small cell lung cancer (NSCLC) with a specific tumor marker.

Patient Parameters

Program Overview

The study aims to find out if combining pembrolizumab and vibostolimab with chemotherapy can help patients with metastatic non-small cell lung cancer (NSCLC) live longer compared to using pembrolizumab with chemotherapy alone. This is specifically for patients whose tumors have a marker called PD-L1 with a score of 1% or higher.

Description

In this study, participants who are receiving the combination of pembrolizumab and vibostolimab with chemotherapy will be switched to the standard treatment of pembrolizumab with chemotherapy. If participants can access the standard treatment outside the study, they may be asked to leave the study. However, those who are benefiting from the treatment and cannot access it outside the study may continue to receive pembrolizumab with chemotherapy until they meet the criteria to stop.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage IV non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
  • Have not received any previous treatment for metastatic NSCLC.
  • Have at least one tumor that can be measured by scans.
  • Expected to live for at least 3 more months.
  • Men must use contraception unless they are confirmed to be unable to father children; women who can become pregnant must use a highly effective birth control method.

Exclusion Criteria

  • Have another cancer that is getting worse or needed treatment in the last 3 years.
  • Have cancer that has spread to the brain or spinal cord or have a specific type of cancer in the brain lining.
  • Have severe allergies to the study drugs or their ingredients.
  • Have an immune system deficiency or are taking high doses of steroids or other immune-suppressing drugs.
  • Have an active autoimmune disease needing treatment in the last 2 years, except for hormone replacement.
  • Have a history of lung inflammation needing steroids or currently have lung inflammation.
  • Have an active infection needing treatment.
  • Have a history of HIV, Hepatitis B, or Hepatitis C.
  • Have received previous cancer treatment for metastatic disease.
  • Have had a live vaccine within 30 days before starting the study treatment.
  • Have had a tissue or organ transplant.
  • Cannot stop taking certain pain relievers or anti-inflammatory drugs for a short period.
  • Cannot or will not take folic acid or vitamin B12 supplements.
  • Are currently in another study or have been in one recently.

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