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Study of adagrasib in elderly patients (70 years or older) or patients with poor performance status who have KRAS G12C mutation-positive non-small cell lung cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with non-small cell lung cancer (NSCLC) that has a specific genetic change called KRASG12C mutation. The study will evaluate a medication called adagrasib (also known as MRTX849), which is given as a film-coated tablet that patients take by mouth. This drug works by blocking a specific protein that contributes to cancer growth.

The research aims to determine how well adagrasib works in treating two specific groups of patients: elderly individuals (70 years and older) and those who have more difficulty performing daily activities due to their cancer. The medication is designed to specifically target lung cancer cells that have the KRASG12C mutation, which is a change in the genetic material of cancer cells.

During the study, participants will receive adagrasib tablets daily. The treatment may continue for up to 13 months, with regular check-ups to monitor how well the treatment is working and any side effects. The maximum daily dose of the medication is 1200 milligrams. Doctors will evaluate how the tumors respond to treatment, how long the treatment remains effective, and how it affects patients' overall health and well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive adagrasib in the form of film-coated tablets that you will take by mouth

    The treatment is intended for patients with non-small cell lung cancer who have a specific genetic change called KRASG12C mutation

  2. Step 2

    Treatment monitoring at 12 weeks

    Your response to treatment will be evaluated after 12 weeks of taking the medication

    Medical imaging will be performed to measure if tumors have responded to the treatment

    Your doctor will assess the results using standardized criteria (RECIST v1.1)

  3. Step 3

    Ongoing assessment phase

    Regular monitoring of your blood counts, kidney function, and liver function will be performed

    Your overall health status and ability to perform daily activities will be evaluated

    You will be asked about how you are feeling and any side effects you may experience

  4. Step 4

    Long-term follow-up

    Your progress will be tracked to measure how long the treatment remains effective

    The medical team will monitor your overall survival and quality of life

    The study will continue until June 2026

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must have confirmed stage IV non-small cell lung cancer (NSCLC)
  • Must have a specific genetic mutation called KRASG12C confirmed by tissue or blood testing
  • Must have received at least one previous treatment for lung cancer (such as chemotherapy or immunotherapy)
  • Must have a life expectancy of at least 12 weeks
  • Must have measurable disease that can be monitored through scans
  • Must belong to one of these groups:
    • Group 1: Age 18 or older with limited ability to perform daily activities (ECOG PS=2)
    • Group 2: Age 70 or older with good ability to perform daily activities (ECOG PS=0-1)
    • Must have adequate blood cell counts, and proper kidney and liver function
    • Must have a negative pregnancy test if able to become pregnant
    • Must be able to follow the study protocol requirements
    • Must provide written informed consent before starting any study procedures

Who cannot join the trial?

13 criteria

  • Prior treatment with a KRAS G12C inhibitor (a type of targeted cancer therapy)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Heart failure requiring treatment
    • Active, uncontrolled infections
    • Known allergy or sensitivity to the study medication or its components
    • Pregnancy or breastfeeding
    • Inability to swallow oral medications
    • Any serious medical condition that could interfere with study participation
    • Current participation in other clinical trials or use of investigational drugs within 28 days before starting this study
    • Any condition that, in the investigator's opinion, would make participation unsafe
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Investigated drugs

Adagrasib is a targeted therapy medication used to treat non-small cell lung cancer (NSCLC) in patients whose cancer has a specific genetic mutation called KRAS G12C. This medication works by blocking the abnormal KRAS protein that helps cancer cells grow and spread. It is taken orally and is specifically designed to help patients who may be elderly or have limited physical functioning due to their condition.

What is already known about the treatment

Adagrasib - A targeted therapy medication administered orally that specifically inhibits the KRAS G12C mutation in non-small cell lung cancer (NSCLC). This novel drug belongs to the class of selective KRAS G12C inhibitors and works by blocking the abnormal protein signaling that drives cancer cell growth. Adagrasib is currently being investigated in clinical trials for patients with KRAS G12C-mutant NSCLC, particularly focusing on elderly patients and those with reduced physical functioning, showing promise as a personalized treatment approach in lung cancer therapy.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation - A specific type of lung cancer characterized by a mutation in the KRAS gene at position G12C. This cancer begins in the lung tissues, specifically in cells that are not small cell type. The disease develops when lung cells with this particular genetic mutation begin to grow uncontrollably and form tumors. NSCLC with KRAS G12C mutation represents a distinct molecular subtype of lung cancer that affects the way cells grow and divide. The disease can spread from the lungs to other parts of the body through the bloodstream or lymphatic system. This condition most commonly occurs in adults and can affect both smokers and non-smokers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510463-35-00Protocol codeETOP 22-22 ADEPPTEstimated enrolment68 patientsSponsorETOP IBCSG Partners Foundation

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).