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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT05673187
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • KRAS P.G12C
  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adagrasib — DRUG
    Adagrasib is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.

Study Details

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).

Key Dates

Start date
Jun 12, 2023
Status verified
Apr 2026
Primary completion
Jul 28, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Adagrasib to be administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks. [ Time Frame: From date of enrolment until 12 weeks post-enrolment ]

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