A Study of Ivonescimab Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants with Unresectable Stage III NSCLC

Prior treatment

• Participants who receive sequential chemoradiation (CRT) for locally advanced NSCLC.
• Any ongoing concomitant chemotherapy, or any immunotherapy, biologic or hormonal therapy for cancer treatment.
• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or to anti-angiogenic therapy administered as anti-cancer therapy.
• History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease, including any active or Grade 2 or higher pneumonitis resulting from prior cCRT.
• Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C).

Lab values

• Known presence of an activating epidermal growth factor receptor (EGFR) mutation based on molecular testing of the tumor or plasma-based testing.

Other

• Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.

• Participants must have histologically- or cytologically-documented NSCLC and present with locally advanced, unresectable (Stage III) disease (according to Version 9 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology]).
• Participants must have received platinum-based chemotherapy concurrent with radiation therapy, which must be completed prior to their first dose of study drug. • The final chemotherapy cycle must end prior to, or concurrently with, the final dose of radiation. Consolidation chemotherapy after radiation is not permitted but administration of chemotherapy prior to concurrent chemoradiation is acceptable.
• Participants must have PD-L1 status with any tumor proportion score (TPS)/tumor cell (TC) score in tumor tissue
• Participants must not have experienced disease progression as defined by RECIST 1.1 criteria following definitive, platinum-based, cCRT.
• Age ≥ 18 years old at the time of enrollment.