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.

Inclusion Criteria

• •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.
• •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 consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• •Age ≥18 at the time of enrolment.
• •Body weight \>30 kg.
• •Life expectancy of at least 12 weeks.
• •Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test at screening before enrolment. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment.
• •Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
• •Eligibility Criteria for randomisation:
• •Known HIV infection that is not well-controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 3 months, CD4+ count of 500 cell per mm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 months on the same anti-HIV medication.
• •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
• •Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
• •Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent.
• •Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• •\- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.
• •Note: Patients in the ADOPT-lung trial, should not receive live vaccine whilst receiving durvalumab and for up to 30 days after the last dose.
• •Concurrent enrolment in another interventional clinical trial.
• •Known allergy or suspected hypersensitivity to durvalumab or its excipients.
• •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
• •Female patients who are pregnant or in the period of lactation.
• •Female patients of childbearing potential and sexually active men who are not willing to use a highly effective contraceptive method during the trial until at least 90 days after the last dose of protocol treatment.