Last updated on November 2019

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours


Brief description of study

PART 1:

Primary objective:

  • To determine the Recommended Phase 2 Dose (RP2D) of BI 836880 in combination with BI 754091 in patients with locally advanced or metastatic non-squamous NSCLC who progressed during or after first line (in case of checkpoint inhibitor nave patients) platinum-based therapy and patients who relapsed after completion of at least 2 cycles (in case of checkpoint inhibitor relapsing patients) of platinum-based chemotherapy and a checkpoint inhibitor treatment (monotherapy or in combination with chemotherapy).

Secondary objective:

  • To provide safety data
  • To 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 patients with locally advanced or metastatic non-squamous NSCLC and other solid tumors

Secondary objective:

  • To provide safety data and further investigate clinical efficacy including disease control (DC), duration of objective response (DoR), progression free survival (PFS), and tumour shrinkage
  • To evaluate the basic pharmacokinetics of BI 836880 and BI 754091 during combination therapy after the first infusion cycle.

Clinical Study Identifier: NCT03468426

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