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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.

NCT06284317 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Adjuvant durvalumab

Durvalumab is given at a fixed dose of 1500 mg i.v. every 4 weeks (±1 week) until relapse or unacceptable toxicity, for a maximum of 12 cycles after surgery.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Solange Peters, MD-PhD · Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland

  • Sabine Schmid, MD · Inselspital, Universitätsspital Bern, 3010 Bern, Switzerland

  • Paul Van Schil, MD-PhD · Antwerp University Hospital, Antwerp, Belgium,

  • Stephen Finn, MD-PhD · St. James's Hospital, Dublin 8, Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2029-10-31
Completion
2030-03-31

Countries

  • Australia
  • Austria
  • Belgium
  • Estonia
  • France
  • Ireland
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284317 on ClinicalTrials.gov