Non-small cell lung cancer (NSCLC): - Locally advanced NSCLC where participants are not candidates for surgical resection and/or definitive chemoradiation, or - Metastatic NSCLC
Conditions
Brief summary
Part A (combination therapy safety lead-in): Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment, Part A (combination therapy safety lead-in): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), changes from baseline in laboratory values/laboratory abnormalities, electrocardiograms (ECGs) and vital signs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), Part A (combination therapy safety lead-in): AEs leading to dose interruption, modification, delays, and permanent treatment discontinuation, Part B (Randomized dose expansion): Objective Response (OR) per investigator assessment using RECIST v1.1
Detailed description
Part A (combination therapy safety lead-in): Objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part B (Randomized dose expansion): Objective response (OR) according to immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): best overall response (BOR), duration of response (DoR), disease control (DC), 6-month durable response (6-month DR) and Progression-Free Survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Overall survival (OS), Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Plasma or serum concentrations of S095018, S095024 or S095029, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Incidence and titer of anti-drug antiodies (ADA) directed against S095018, S095024 or S095029, Part B (Randomized dose expansion): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), changes in laboratory values/laboratory abnormalities, ECGs and vital signs according to NCI-CTCAE v5.0, Part B (Randomized dose expansion): AEs leading to dose interruption, modification, delays, and permanent treatment discontinuation
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A (combination therapy safety lead-in): Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment, Part A (combination therapy safety lead-in): Incidence and severity of adverse events (AEs), serious adverse events (SAEs), changes from baseline in laboratory values/laboratory abnormalities, electrocardiograms (ECGs) and vital signs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), Part A (combination therapy safety lead-in): AEs leading to dose interruption, modification, delays, and permanent treatment discontinuation, Part B (Randomized dose expansion): Objective Response (OR) per investigator assessment using RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A (combination therapy safety lead-in): Objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part B (Randomized dose expansion): Objective response (OR) according to immune Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): best overall response (BOR), duration of response (DoR), disease control (DC), 6-month durable response (6-month DR) and Progression-Free Survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator, Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Overall survival (OS), Part A (combination therapy safety lead-in) and Part B (Randomized dose expansion): Plasma or serum concentration | — |
Countries
Austria, Belgium, France, Hungary, Italy, Romania, Spain