Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status (NCT05673187) | Clinical Trial Compass
Active â Not RecruitingPhase 2
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
Belgium, France68 participantsStarted 2023-06-12
Plain-language 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 (â¥70 years) or patients with poor performance status (ECOG PS=2).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
â. Histologically or cytologically confirmed stage IV NSCLC.
â. KRASG12C-mutation by local testing (by tissue or ctDNA).
â. 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).
â. Life expectancy â¥12 weeks.
â. Measurable disease according to RECIST v1.1.
â. Age â¥18 years with ECOG PS 2 (cohort 1), or age â¥70 years with ECOG PS 0-1 (cohort 2).
â. Adequate haematological, renal and liver function
â. Men and women of childbearing potential must agree to use use highly effective contraceptive methods.
Exclusion criteria
â. Prior investigational therapy within 28 days or at least 5 half-lives before enrolment.
â. Prior treatment with an agent targeting KRASG12C.
â. Leptomeningeal disease or untreated brain metastases.
â. History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
â. Any of the following cardiac abnormalities:
What they're measuring
1
Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks.
Timeframe: From date of enrolment until 12 weeks post-enrolment
â. History of stroke or transient ischemic attack within 6 months prior to enrolment.
â. 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.
â. Known human immunodeficiency virus (HIV) infection.