Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

Last updated: July 9, 2025
Sponsor: ETOP IBCSG Partners Foundation
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Adagrasib

Clinical Study ID

NCT05673187
ETOP 22-22
2022-002736-31
  • Ages > 18
  • All Genders

Study Summary

ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).

Eligibility Criteria

Inclusion

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 effectivecontraceptive methods.

  9. Women of childbearing potential, including women who had their last menstruation inthe last 2 years, must have a negative urinary or serum beta HCG pregnancy testwithin 5 weeks before enrolment. Pregnancy test must be repeated within 7 daysbefore the first dose of adagrasib treatment.Ability to comply with the trialprotocol, in the investigator's judgment.

  10. Written IC for study participation must be signed and dated by the patient and theinvestigator prior to any study-related intervention, including the submission ofmandatory biomaterial.

Exclusion

Exclusion Criteria:

  1. Prior investigational therapy within 28 days or at least 5 half-lives beforeenrolment.

  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 ofminimum of 2 weeks must have elapsed from the last day of radiotherapy.

  1. History of intestinal disease or major gastric surgery likely to alter absorption ofstudy treatment or inability to swallow oral medications.

  2. Any of the following cardiac abnormalities:

  • Unstable angina pectoris or myocardial infarction within 6 months prior toenrolment.

  • Symptomatic or uncontrolled atrial fibrillation within 6 months prior toenrolment.

  • Congestive heart failure ≥NYHA Class 3 within 6 months prior to enrolment.

  • Prolonged QTc interval >480 ms or family or medical history of congenital LongQT Syndrome.

  1. History of stroke or transient ischemic attack within 6 months prior to enrolment.

  2. Ongoing need for treatment with concomitant medication with any of the followingcharacteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrowtherapeutic 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 toenrolment.

  3. Known human immunodeficiency virus (HIV) infection.

  4. Acute or chronic hepatitis B or C infection.

  5. Women who are pregnant or in the period of lactation.

  6. Sexually active men and women of childbearing potential who are not willing to usean effective contraceptive method during the study.

  7. Judgement by the investigator that the patient should not participate in the studyif the patient is unlikely to comply with study procedures, restrictions andrequirements.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: Adagrasib
Phase: 2
Study Start date:
June 12, 2023
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Instiute Jules Bordet

    Brussels,
    Belgium

    Site Not Available

  • Centre Hospitalier d'Avignon

    Avignon,
    France

    Site Not Available

  • Caen - CHU

    Caen,
    France

    Site Not Available

  • Le Mans - CHG

    Le Mans,
    France

    Site Not Available

  • Hôpital de Marseille

    Marseille,
    France

    Site Not Available

  • Cork University Hospital

    Cork,
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin,
    Ireland

    Site Not Available

  • St James's Hospital

    Dublin,
    Ireland

    Site Not Available

  • Galway University Hospital

    Galway,
    Ireland

    Site Not Available

  • University Hospital Limerick

    Limerick,
    Ireland

    Site Not Available

  • University Hospital Waterford

    Waterford,
    Ireland

    Site Not Available

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia,
    Italy

    Site Not Available

  • Santa Maria della Misericordia Hospital

    Perugia,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori "Regina Elena"

    Rome,
    Italy

    Site Not Available

  • AULSS2 Marca Trevigiana Treviso

    Treviso,
    Italy

    Site Not Available

  • Complejo Hospitalario Universitario a Coruña

    A Coruña,
    Spain

    Site Not Available

  • Alicante University Hospital

    Alicante,
    Spain

    Site Not Available

  • ICO Badalona - Hospital Germans Trias i Pujol

    Badalona,
    Spain

    Site Not Available

  • Hospital de Basurto

    Bilbao,
    Spain

    Site Not Available

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

    L'Hospitalet De Llobregat,
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid,
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia (University Hospital Valencia)

    Valencia,
    Spain

    Site Not Available

  • Royal Marsden Hospital (Chelsea)

    London,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital (Sutton)

    London,
    United Kingdom

    Site Not Available

  • Maidstone & Tunbridge Wells

    Maidstone,
    United Kingdom

    Site Not Available

  • Christie NHS Manchester

    Manchester,
    United Kingdom

    Site Not Available

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