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.

ADEPPT: Adagrasib in patients with KRASG12C-mutant NSCLC who are elderly or have poor performance status

The aim of the 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).

Trial Scheme

USZ STRIKE trial schema

Trial Information

Primary Endpoint:
Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks
Secondary Endpoints:
Durable clinical benefit
Time to progression
Progression-free Survival
Overall Survival
Safety
Patient-related outcomes
Target Sample Size:
68 enrolled patients
Protocol Release Date:
15 July 2022
Trial Activation Date
26 April 2023
First Patient In:
12 June 2023

Trial Organisation

Trial Chair:
Jarushka Naidoo, Dublin, Ireland
Trial Co-Chairs:
Colin Lindsay, Manchester, United Kingdom
Bartomeu Massuti, Alicante, Spain
Sponsor:
ETOP IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation, in collaboration with Cancer Trials Ireland (CTI) and Spanish Lung Cancer Group (SLCG) 
Participating Countries:   
Belgium, France, Ireland, Italy, Spain, United Kingdom
Registrations:
EudraCT number: 2022-002736-31
clinicaltrials.gov: NCT05673187

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
ADEPPT@etop.ibcsg.org

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