Testing Targeted Treatment (AMG 510) for Advanced Lung Cancer with KRAS G12C Mutation

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04625647

Provider View

This clinical trial is exploring the effects of a new drug, AMG 510, on advanced non-squamous non-small cell lung cancer that has a specific genetic mutation called KRAS G12C. The study aims to see if this targeted treatment can help stop the growth of cancer cells.

Patient Parameters

Program Overview

This phase II study is testing a new drug called AMG 510 for treating advanced non-squamous non-small cell lung cancer (NSCLC) that has a specific mutation in the KRAS gene, known as KRAS G12C. This mutation can cause cancer to grow, and AMG 510 is designed to target and stop this growth. The trial will evaluate how well the drug works in shrinking tumors and improving survival rates, as well as its safety and any side effects.

Description

The main goal of this study is to see how well AMG 510 works in shrinking tumors in patients with advanced lung cancer that has the KRAS G12C mutation. Researchers will also look at how long patients live without the cancer getting worse and how long the treatment effects last. They will monitor any side effects experienced by participants.

The study will also explore how other genetic changes in the cancer might affect treatment outcomes and will collect blood samples to study circulating tumor DNA.

Participants will take AMG 510 by mouth once a day in 21-day cycles, continuing as long as the treatment is effective and side effects are manageable. After finishing the treatment, patients will have follow-up visits every 3 months for 3 years if the cancer has not worsened, or every 6 months for 2 years if it has.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the S1900E study group, determined by specific genetic testing.
  • Have stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) with less than 50% squamous cells.
  • Have measurable cancer as shown by CT or MRI scans.
  • Have a recent brain scan to check for cancer spread to the brain.
  • If HIV positive, must be on treatment with an undetectable viral load.
  • Have tried all standard treatments for certain genetic mutations if present.
  • Have controlled brain or spinal cord cancer spread.
  • Have had at least one previous treatment for advanced NSCLC.
  • Cancer must have worsened after the last treatment.
  • Must have recovered from side effects of previous treatments.
  • Must be able to swallow pills.
  • Recent medical exam and blood tests showing adequate health.
  • Must agree to provide blood samples for research.
  • Must understand the study and agree to participate.

Exclusion Criteria

  • Cannot have unresolved neurological issues from brain or spinal cord cancer spread.
  • Cannot have cancer spread to the brain lining unless it is symptom-free and only seen on scans.
  • Cannot have had recent cancer treatments or major surgery.
  • Cannot have used AMG 510 or similar drugs before.
  • Cannot plan to use other cancer treatments during the study.
  • Cannot have serious heart conditions or other cancers that interfere with the study.
  • Cannot have digestive issues affecting drug absorption.
  • Cannot use certain medications that affect drug processing in the body.
  • Cannot be pregnant or breastfeeding and must agree to use birth control during and after the study.

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