Study Comparing Sotorasib (AMG 510) with Docetaxel for Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04303780

Provider View

This clinical trial is comparing two treatments, Sotorasib (AMG 510) and Docetaxel, for patients with Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic mutation known as KRAS p.G12C.

Patient Parameters

Program Overview

The purpose of this Phase 3 study is to compare the effectiveness of Sotorasib (AMG 510) with Docetaxel in treating patients with Non-Small Cell Lung Cancer (NSCLC) who have a specific mutation called KRAS p.G12C. This mutation is confirmed through testing before patients can join the study.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have been diagnosed with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery and has the KRAS p.G12C mutation, confirmed through specific testing.

Exclusion Criteria

  • Have active cancer that has spread to the brain.
  • Have had a heart attack within the last 6 months.
  • Have a gastrointestinal condition that prevents taking oral medication.

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