IFCT-1802 SAVIMMUNE A phase II single-arm trial evaluating safety and efficacy of Durvalumab in ECOG Performance Status 2-3, treatment-naive, patients with stage IV Non-Small Cell Lung Cancer (NSCLC) and high PD-L1 tumor expression

Non small cell lung cancer, Poor general status

Percentage of patients experiencing Grade 3-5 TRAEs at 8 weeks of durvalumab

Safety analysis : The maximum grade or adverse event will be summarized by frequency and proportion of total patients, by system organ class, Disease Control Rate at 8 weeks (percentage of patients with objective response or stable disease according to RECISTS 1.1 in the intent to treat population)., Objective Response Rate at 8 weeks according to RECIST 1.1 in the intent to treat population., PFS from the date of durvalumab initiation to progression date or death; PFS curves, PFS medians with 95% CIs, and PFS rates at 6 and 12 months with 95% CIs will be estimated using Kaplan-Meier methodology., OS from the date of durvalumab initiation to the date of death. OS curves, OFS medians with 95% CIs, and OFS rates at 6 and 12 months with 95% CIs will be estimated using Kaplan-Meier methodology., Performance status improvement rate, defined as the proportion of per-protocol patients whose PS was improved from baseline during durvalumab treatment., Quality of Life using EORTC QLQ-C30/QLQ-LC13 and EQ-5D questionnaires, and time until definitive HRQoL score deterioration (TUDD)., Centrally-assessed PD-L1 tumor expression : prognostic and predictive value using SP263 antibodies

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