Phase I clinical trial - Appareil pulmonaire

PART 1:;Primary objective:;- To determine the Recommended Phase 2 Dose (RP2D) of BI 836880 in combination with BI 754091 in check point inhibitor na´ve patients with locally advanced or metastatic non-squamous NSCLC who progressed during or after first line platinum based treatment.;Secondary objective:;ÀTo provide safety data;ÀTo evaluate the basic pharmacokinetics of BI 836880 and BI 754091 during combination therapy after the first and fourth infusion cycle.;PART 2:;Primary objective:;- To assess anti-tumour activity of BI 836880 in combination with BI 754091 in check point inhibitor na´ve patients with locally advanced or metastatic non-squamous NSCLC who progressed during or after first line platinum-based treatment .;ÀCohort A: Patients with locally advanced or metastatic non-squamous NSCLC with low PD-L1 expression (PD-L1 expression in 1-49% of tumor cells);ÀCohort B: Patients with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (PD-L1 expression in = 50% of tumor cells);Secondary objective:;ÀTo provide preliminary safety data and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression free survival (PFS), and tumour shrinkage;ÀTo evaluate the basic pharmacokinetics of BI 836880 and BI 754091 during combination therapy after the first and fourth infusion cycle.