OncoMatch/Clinical Trials/NCT06284317
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.
Is NCT06284317 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Adjuvant durvalumab for non small cell lung cancer.
Treatment: Adjuvant durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Required: EGFR wild-type
Disease stage
Required: Stage IIB, IIIA, IIIB (8th edition of the TNM staging system of lung cancer)
Excluded: Stage IIIB N3, T4 WITH INVASION OF HEART, GREAT VESSELS, CARINA, TRACHEA, OESOPHAGUS, OR SPINE
Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer. T4 tumours will only be eligible if they are defined as T4 based only on their size (>7cm); any other reason will be considered ineligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any previous or concurrent treatments for NSCLC
Any previous or concurrent treatments for NSCLC.
Cannot have received: immunotherapy
Any previous immunotherapy.
Lab requirements
Blood counts
Haemoglobin ≥90 g/L, Absolute neutrophil count (ANC) ≥1.0× 10^9/L, Platelet count ≥75× 10^9/L
Kidney function
Measured creatinine clearance (CL) >40 mL/min or calculated CL >40 mL/min calculated by the Cockcroft-Gault
Liver function
ALT and AST ≤2.5× institutional ULN, Total serum bilirubin ≤1.5× institutional ULN (patients with Gilbert's syndrome may be allowed to be enrolled after consultation)
Adequate haematological function: Haemoglobin ≥90 g/L, ANC ≥1.0× 10^9/L, Platelet count ≥75× 10^9/L. Adequate renal function: CL >40 mL/min. Adequate liver function: ALT and AST ≤2.5× ULN, Total serum bilirubin ≤1.5× ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06284317 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIB or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify