- 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. — Recruiting • Phase III • Oncology • NCT06284317.
- What is being tested: The addition of adjuvant (post-operative) durvalumab (PD-L1 inhibitor) versus observation alone, following neoadjuvant durvalumab plus chemotherapy and surgical resection in early-stage, operable NSCLC.
- Patient eligibility overview: Adults with stage IB-IIIB, operable non-small cell lung cancer who complete neoadjuvant durvalumab-chemotherapy and undergo R0/R1 surgical resection are eligible for randomisation into the adjuvant phase.
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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…
- for enrolment: * Histologically confirmed NSCLC. * Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer. Stage III assessment should include samples of lymph nodes at levels 4, bilaterally, and level 7 to rule out stage IIIB N3 disease. 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. * Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is done with the Ventana PD-L1 (SP263) assay. * Absence of EGFR mutation or ALK translocation, as tested locally. * Primary tumour resectable and functionally operable as assessed per local multidisciplinary tumour board (cardiac evaluation, pulmonary function and diffusion capacity, comorbidity). * Adequate haematological function: Haemoglobin ≥90 g/L, Absolute neutrophil count (ANC) ≥1.0× 109/L, Platelet count ≥75× 109/L. - Adequate renal function: Measured creatinine clearance (CL) >40 mL/min or calculated CL >40 mL/min calculated by the Cockcroft-Gault. - Adequate 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.