A study to evaluate the benefit of adding durvalumab after chemotherapy, durvalumab and surgery in patients with early-stage, operable, non-small cell lung cancer.

Phase 3

Recruiting

• Conditions: Stage IIB-IIIB (N2) resectable non small cell lung cancer

• Registration Number: 2023-508773-82-00
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief Summary

ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2025-01-15
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-09-30
• Primary Completion: 2029-10
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DFS in patients without pCR, measured from randomisation.		DFS in patients without pCR, measured from randomisation.

Secondary Outcome Measures

Name	Time	Method
Assessed in the adjuvant treatment phase (after randomisation) • DFS in patients with pCR. • Overall survival (OS) in patients with/without pCR, ITT. • DFS in patients with/without ctDNA clearance. • Time to recurrence (TTR) in patients with/without pCR, ITT. • Time to treatment discontinuation (TTD) in patients with/without pCR, ITT. • Toxicity according to CTCAE v5.0.		Assessed in the adjuvant treatment phase (after randomisation) • DFS in patients with pCR. • Overall survival (OS) in patients with/without pCR, ITT. • DFS in patients with/without ctDNA clearance. • Time to recurrence (TTR) in patients with/without pCR, ITT. • Time to treatment discontinuation (TTD) in patients with/without pCR, ITT. • Toxicity according to CTCAE v5.0.
Key secondary endpoint: (hierarchically tested) DFS in the ITT cohort (with and without pCR), measured from randomisation.		Key secondary endpoint: (hierarchically tested) DFS in the ITT cohort (with and without pCR), measured from randomisation.

Trial Locations

Locations (42)

Chris O'Brien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Nepean Hospital; 🇦🇺 Penrith, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

Eastern Health; 🇦🇺 Box Hill, Victoria, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Parkville, Victoria, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

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