Study Comparing Sotorasib with Chemotherapy to Pembrolizumab with Chemotherapy for Advanced Non-Small Cell Lung Cancer

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05920356

Provider View

This clinical trial is comparing two different treatment combinations for patients with advanced non-small cell lung cancer (NSCLC). The study aims to see which combination helps patients live longer without the cancer getting worse.

Patient Parameters

Program Overview

The main goal of this study is to compare how long patients with advanced non-small cell lung cancer (NSCLC) can live without their cancer progressing when treated with either sotorasib combined with chemotherapy or pembrolizumab combined with chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not squamous type and has a specific KRAS mutation (G12C).
  • Cancer must be at stage IV or advanced stage IIIB/C.
  • Tested negative for PD-L1 expression.
  • Have not received any previous systemic treatment for cancer that has spread or cannot be cured.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have a type of lung cancer that includes small-cell or large-cell neuroendocrine cells, or mainly squamous cells.
  • Have tumors with specific genetic changes that have approved targeted treatments.
  • Have brain metastases that are causing symptoms, whether treated or not.
  • Have digestive system issues that prevent taking oral medication.
  • Have had a heart attack in the last 6 months, or have unstable heart rhythms or chest pain.
  • Have previously been treated with a KRAS G12C inhibitor.

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