NCT05673187

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• NSCLC Stage IV
• KRAS P.G12C

Interventions

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

Timeline

• Start date: 2023-06-12
• Primary completion: 2025-07-28
• Completion: 2026-03-01
• First posted: 2023-01-06
• Last updated: 2026-01-21

Locations

22 sites across 6 countries: Belgium, France, Ireland, Italy, Spain, United Kingdom