Phase III Study of Dato-DXd and Rilvegostomig for Advanced Non-squamous NSCLC with High PD-L1 Levels

Inclusion Criteria

• Diagnosed with non-squamous non-small cell lung cancer (NSCLC).
• Cancer is at an advanced stage (IIIB, IIIC, or IV) and cannot be treated with surgery or radiation.
• No specific genetic changes like EGFR mutations or ALK and ROS1 rearrangements that can be treated with other drugs.
• Must provide a tumor sample to check PD-L1 and TROP2 levels and other markers.
• Known PD-L1 levels of TC ≥ 50%.
• At least one measurable tumor that has not been treated with radiation.
• Good overall health with an ECOG performance status of 0 or 1.
• Adequate blood and organ function before starting the study treatment.

Exclusion Criteria

• Have received previous treatment for advanced/metastatic NSCLC.
• Have squamous cell lung cancer or mixed types like small cell lung cancer.
• Have had another cancer within the last 3 years.
• Have active or past autoimmune or inflammatory disorders, with some exceptions.
• Have severe or uncontrolled diseases, including bleeding, infections, or lung diseases like ILD/pneumonitis.
• Have fluid buildup in the body that cannot be drained.
• Have lung issues that required steroids or have current lung problems.
• Have untreated spinal cord compression or brain metastases unless stable and not needing treatment.
• Have a history of cancer spread to the brain lining.
• Have significant eye diseases.
• Have active infections like TB, hepatitis, or uncontrolled HIV.
• Have a history of immune system disorders.