A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)

This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)

This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).

Inclusion Criteria:

• Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
• No prior chemotherapy or any other systemic therapy for metastatic NSCLC
• Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred >12 months from end of last therapy
• Known tumor PD-L1 status
• Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
• WHO/ECOG status at 0 or 1 at enrollment
• Life expectancy of at least 12 weeks
• Troponin I or T ≤ ULN (per institutional guidelines)

Exclusion Criteria:

• Active or prior documented autoimmune or inflammatory disorders
• History of active primary immunodeficiency
• Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
• Untreated CNS metastases