A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Eligibility Criteria

• 1. Participant must be ≥ 18 years at the time of screening.
• 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
• 3. Provision of a tumour tissue sample obtained prior to CRT
• 4. Documented tumour PD-L1 status ≥ 1% by central lab
• 5. Documented EGFR and ALK wild-type status (local or central).
• 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
• 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
• 8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
• 9. WHO performance status of 0 or 1 at randomization
• 10. Adequate organ and marrow function
• 1. History of another primary malignancy, except for:
• * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
• * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
• * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
• 2. Mixed small cell and non-small cell lung cancer histology.
• 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
• 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
• 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
• 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
• 7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
• 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
• 9. Active EBV infection, or known or suspected chronic active EBV infection at screening
• 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.