A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (ALTAIR)

Condition studied

metastatic non-small cell lung cancer (NSCLC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part A: Safety run-in. Safety and tolerability will be evaluated in terms of DLT (to determine the recommended dose), AEs/SAEs, imAEs, AEs leading to discontinuation, laboratory findings, ECGs, vital signs, and physical examinations.The estimates of interest are:-Incidence of AEs/SAEs, imAEs, and AEs leading to discontinuation -Incidence of DLTs-Mean changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination., Part B: Dose expansion Safety and tolerability will be evaluated in terms of AEs/SAEs, imAEs, AEs leading to discontinuation, laboratory findings, ECGs, vital signs, and physical examinations.The estimates of interest are:Incidence of AEs/SAEs, imAEs, and AEs leading to discontinuation.Mean changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination., Part B: Dose expansion :Objective response is defined as BOR of confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST1.1. The estimate of interest is • OR The analysis will include participants in the Response Evaluable Analysis Set. Participants will be analyzed according to their planned treatment and indication

Endpoint detail

Part A: Safety run-in • OR • DOR, TTR, DC • PFS and OS, Part B: Dose expansion :•DOR, TTR, DC (similar to Part A efficacy) •PFS (similar to Part A efficacy) •OS (similar to Part A efficacy), All parts of the study :Serum concentrations and derived PK parameters of novel agents, All parts of the study:Incidence of ADAs against novel agents in serum