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Adagrasib treatment for elderly patients with KRASG12C-mutant lung cancer

A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status

Phase 2 Interventional ETOP IBCSG Partners Foundation · NCT05673187

This study is testing if a new oral medication called adagrasib can help older patients with a specific type of lung cancer feel better after they’ve already tried other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment68 (estimated)
Ages18 Years and up
SexAll
SponsorETOP IBCSG Partners Foundation Research network
Drugs / interventionschemotherapy, prednisone
Locations22 sites (Brussels and 21 other locations)
Trial IDNCT05673187 on ClinicalTrials.gov

What this trial studies

This international, multicenter, single-arm phase II trial evaluates the efficacy of adagrasib, administered orally at a dose of 600 mg twice daily, in patients with stage IV non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation. The study focuses on elderly patients aged 70 and above or those with poor performance status (ECOG PS=2) who have previously received systemic therapy. The primary goal is to assess the objective response rate to the treatment until disease progression or unacceptable toxicity occurs.

Who should consider this trial

Good fit: Ideal candidates include patients aged 70 years or older with stage IV KRASG12C-mutant NSCLC or those aged 18 and older with an ECOG performance status of 2.

Not a fit: Patients with stage IV NSCLC who do not have the KRASG12C mutation or those with a performance status better than ECOG PS 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for elderly patients or those with poor performance status suffering from KRASG12C-mutant NSCLC.

How similar studies have performed: Other studies targeting KRAS mutations have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Histologically or cytologically confirmed stage IV NSCLC.
2. KRASG12C-mutation by local testing (by tissue or ctDNA).
3. Prior treatment with at least one line of systemic therapy for NSCLC (e.g., platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).
4. Life expectancy ≥12 weeks.
5. Measurable disease according to RECIST v1.1.
6. Age ≥18 years with ECOG PS 2 (cohort 1), or age ≥70 years with ECOG PS 0-1 (cohort 2).
7. Adequate haematological, renal and liver function
8. Men and women of childbearing potential must agree to use use highly effective contraceptive methods.
9. Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum beta HCG pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 7 days before the first dose of adagrasib treatment.Ability to comply with the trial protocol, in the investigator's judgment.
10. Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention, including the submission of mandatory biomaterial.

Exclusion Criteria:

1. Prior investigational therapy within 28 days or at least 5 half-lives before enrolment.
2. Prior treatment with an agent targeting KRASG12C.
3. Leptomeningeal disease or untreated brain metastases.

   * Patient should be neurologically stable for at least 2 weeks before enrolment, without the need for corticosteroids, except for prednisone (or its equivalent) at a dose of ≤10 mg daily.
   * For patients with definitively treated brain metastases, a time period of minimum of 2 weeks must have elapsed from the last day of radiotherapy.
4. History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
5. Any of the following cardiac abnormalities:

   * Unstable angina pectoris or myocardial infarction within 6 months prior to enrolment.
   * Symptomatic or uncontrolled atrial fibrillation within 6 months prior to enrolment.
   * Congestive heart failure ≥NYHA Class 3 within 6 months prior to enrolment.
   * Prolonged QTc interval \>480 ms or family or medical history of congenital Long QT Syndrome.
6. History of stroke or transient ischemic attack within 6 months prior to enrolment.
7. Ongoing need for treatment with concomitant medication with any of the following characteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors that cannot be switched to alternative treatment prior to enrolment.
8. Known human immunodeficiency virus (HIV) infection.
9. Acute or chronic hepatitis B or C infection.
10. Women who are pregnant or in the period of lactation.
11. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
12. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Where this trial is running

Brussels and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NSCLC Stage IVKRAS P.G12C
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.