TROPION Lung 10

1. Histologically or cytologically documented NSCLC that is (a) Stage IIIB or IIIC disease not amenable for surgical resection or definitive chemoradiation, or Stage IV metastatic NSCLC disease at the time of randomisation who have not received prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC. (b) Lacks sensitizing EGFR mutation (c) no known genomic alterations.

2. ECOG 0-1.

3. FFPE tumour sample collected < 3 months prior to signing informed consent.

4. Tumour PD-L1 status defined as TC equal to or > 50%.

5. Adequate bone marrow, minimum life expectancy of 12 weeks. 

1. Any evidence of diseases or history of allogenic organ transplant, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.

2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, lentigo maligna that has undergone potentially curative therapy or adequately treated in situ disease without evidence of recurrence.

3. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.

4. Persistent toxicities caused by previous anti-cancer therapy, excluding alopecia or vitiligo, not yet improved to Grade ≤ 1 or baseline.

5. Active or prior documented autoimmune, connective tissue or inflammatory disorders, autoimmune pneumonitis and autoimmune myocarditis.

6. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 7 days prior to randomisation.

7. History of leptomeningeal carcinomatosis.

8. Clinically significant corneal disease. 

Research Nurse: Sirjana Davkota (x3766) Sirjana.Davkota@lthtr.nhs.uk

Administrator: Nathan Fish (x8475)