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A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study)

Primary Objective To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by RECIST 1.1 among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. Secondary and Exploratory Objectives To estimate the duration of response (DoR) among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1. To estimate the duration of response (DoR) per immune-related response criteria among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1 To evaluate overall survival (OS) among patients treated with MEDI4736 (Durvalumab) plus tremelimumab To evaluate investigator-assessed progression-free survival (IA-PFS) among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) as defined in Section 10.1 among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. To evaluate the frequency and severity of toxicities associated with MEDI4736 (Durvalumab) plus tremelimumab. Translational Medicine Objectives To explore the association of potential predictive markers identified in S1400A, with response and progression-free survival (PFS). To explore the association of PD-L1 expression status with response and PFS. To contribute to an ongoing serum and tumor bank in S1400.

Primary Objective To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by RECIST 1.1 among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. Secondary and Exploratory Objectives To estimate the duration of response (DoR) among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1. To estimate the duration of response (DoR) per immune-related response criteria among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1 To evaluate overall survival (OS) among patients treated with MEDI4736 (Durvalumab) plus tremelimumab To evaluate investigator-assessed progression-free survival (IA-PFS) among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) as defined in Section 10.1 among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. To evaluate the frequency and severity of toxicities associated with MEDI4736 (Durvalumab) plus tremelimumab. Translational Medicine Objectives To explore the association of potential predictive markers identified in S1400A, with response and progression-free survival (PFS). To explore the association of PD-L1 expression status with response and PFS. To contribute to an ongoing serum and tumor bank in S1400.