Phase I clinical trial - Appareil pulmonaire

BI 1336-0011
Appareil pulmonaire
Ouvert depuis le: 05.27.2020
Site: Paris
Public cible
Adulte
An Open Label Phase Ib Dose Finding Study of BI 836880 in Combination With BI 754091 to Characterize Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy in Check Point Inhibitor naïve Patient With Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Progressed During or After First Line Platinum-based Treatment.
Description de l'essai

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.