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New hope for elderly lung cancer patients: targeted pill shows promise

NCT ID NCT05673187

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests a daily pill called adagrasib in 68 patients with a specific type of advanced lung cancer (KRAS G12C mutation) who are either 70 or older or have poor physical health. The goal is to see if the drug can shrink tumors or stop them from growing. Patients take the medication twice a day until their disease gets worse or side effects become too severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

KRAS P.G12C NSCLC stage IV

Contacts and locations

Locations

  • AULSS2 Marca Trevigiana Treviso

    Treviso, Italy

  • Alicante University Hospital

    Alicante, Spain

  • Beaumont Hospital

    Dublin, Ireland

  • Christie NHS Manchester

    Manchester, United Kingdom

  • Complejo Hospitalario Universitario a Coruña

    A Coruña, Spain

  • Hospital General Universitario de Valencia (University Hospital Valencia)

    Valencia, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, Spain

  • Hospital de Basurto

    Bilbao, Spain

  • Hôpital de Marseille

    Marseille, France

  • ICO Badalona - Hospital Germans Trias i Pujol

    Badalona, Spain

  • ICO Bellvitge -H. Duran i Reynals / H. Bellvitge

    L'Hospitalet de Llobregat, Spain

  • Instiute Jules Bordet

    Brussels, Belgium

  • Istituto Nazionale Tumori "Regina Elena"

    Rome, Italy

  • Le Mans - CHG

    Le Mans, France

  • Santa Maria della Misericordia Hospital

    Perugia, Italy

  • University Hospital Limerick

    Limerick, Ireland

  • University Hospital Waterford

    Waterford, Ireland

More trials for these conditions

Other studies related to the condition(s) this trial covers.