Phase Ia - Dose Escalation The main objective of the dose-escalation part is to determine the maximum tolerated dose (MTD) of BI 907828 in combination with BI 754091 and BI 754111, based on the frequency of patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for further development of BI 907828 in combination with BI 754091 and BI 754111, and to evaluate safety and tolerability of BI 907828 in combination with BI 754091 and BI 754111 by monitoring the occurrence and severity of adverse events (AEs). The secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 907828, BI 754091 and BI 754111 based on Cmax and AUC0-tz, and the preliminary assessment of anti-tumor activity. Phase Ib - Dose Expansion The main objective of the dose-expansion part is to assess the preliminary efficacy of the combination of BI 907828, BI 754091, and BI 754111. The secondary and further objectives are to further assess the safety, the PK profiles at the recommended dose for expansion (RDE), and to determine the Recommended Phase II Dose (RP2D).
Name: BI 907828
Description: Film-coated tabletsType: DrugDose Escalation - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+BI 754111 Dose Expansion - Cohort 1 - Arm C - BI 907828 + BI 754091 Dose Expansion - Cohort 2 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 3 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 4 - BI 907828 + BI 754091 + BI 754111
Name: BI 754091
Description: Solution for infusionType: DrugDose Escalation - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+BI 754111 Dose Expansion - Cohort 1 - Arm B - BI 754091 + BI 754111 Dose Expansion - Cohort 2 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 3 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 4 - BI 907828 + BI 754091 + BI 754111
Name: BI 754111
Description: Solution for infusionType: DrugDose Escalation - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+BI 754111 Dose Expansion - Cohort 1 - Arm B - BI 754091 + BI 754111 Dose Expansion - Cohort 2 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 3 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 4 - BI 907828 + BI 754091 + BI 754111
Allocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
Patients with NSCLC harboring genomic aberrations for which FDA approved targeted therapy is available such as non-resistant EGFR mutations, EGFR T790M mutation, ALK rearrangement, ROS re-arrangement, and BRAF V600E mutation, must have received prior treatment with FDA-approved targeted therapy. --- T790M ---
Patients with NSCLC harboring genomic aberrations for which FDA approved targeted therapy is available such as non-resistant EGFR mutations, EGFR T790M mutation, ALK rearrangement, ROS re-arrangement, and BRAF V600E mutation, must have received prior treatment with FDA-approved targeted therapy. --- T790M --- --- V600E ---