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25-23 ADOPT-lung

Details

An international, multicentre, open-label randomised phase III trial to evaluate the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable NSCLC

The aim of this trial is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant treatment with platinum-based doublet chemotherapy plus durvalumab has an effect on disease-free survival in patients not achieving a complete pathological response and in the overall patient population.

Trial Scheme

Trial Information

Primary Endpoint:
DFS in patients without pCR, measured from randomisation
Secondary Endpoints:
Neoadjuvant treatment phase:
Response rate
Proportion of patients undergoing surgery
Proportion of patients with surgical outcome R0 and R1
CR rate
Proportion of patients eligible for randomisation
Proportion of patients effectively randomised

Adjuvant treatment phase:
DFS in patients with pCR (with/without ctDNA clearance)
Overall survival
Time to recurrence
Time to treatment discontinuation
Toxicity
Target Sample Size:
520 enrolled patients
Protocol Release Date:
16 February 2024

Trial Organisation

Trial Chair:
Solange Peters, Lausanne, Switzerland
Trial Co-Chair:
Sabine Schmid, Berne, Switzerland
Sponsor:
ETOP IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation
Participating Groups:
Swiss Group for Clinical Cancer Research (SAKK) and Thoracic Oncology Group Australia (TOGA)
Participating Countries:
Austria, Australia, Belgium, France, Italy, Estonia, Switzerland, UK
Registrations:
EU CT number: 2023-508773-82
clinicaltrials.gov: NCT06284317

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
ADOPT-lung@etop.ibcsg.org