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NCT06284317Not yet recruiting

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.

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
ETOP IBCSG Partners FoundationPhase 3ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Adjuvant durvalumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
ETOP IBCSG Partners Foundation
Timeline & enrollment
Phase
Phase 3
Start date
Oct 01, 2024
End date
Jan 01, 2030
Enrollment
290 participants
Primary outcome

Disease-free survival (DFS)

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.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06284317
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06284317 through Pure Global AI's free database. This Phase 3 trial is sponsored by ETOP IBCSG Partners Foundation and is currently Not yet recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 290 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.