Lung Cancer, Non-Small Cell
Conditions
Brief summary
The primary efficacy endpoint ORR will be valuated by RECIST v1.1 based on BICR and will be defined as the proportion of participants with BOR of CR or PR in the analysis population.
Detailed description
- OS will be defined as the time from the date of randomization to the date of death by any cause. - PFS will be evaluated using RECIST v1.1 based on Investigator assessment and will be defined as the time from the date of randomization to the date of PD or death by any cause, whichever occurs first., Assess the incidence of TEAEs, SAEs, irAEs, TEAEs leading to death, and AEs leading to discontinuation occurring while participants are on treatment or up to 90 days after the last dose of study treatment. Clinical laboratory parameters (hematology, chemistry, thyroid function, urinalysis), vital signs, ECOG performance status, ECG parameters, physical examinations, and usage of concomitant medications will be collected.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCarboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint ORR will be valuated by RECIST v1.1 based on BICR and will be defined as the proportion of participants with BOR of CR or PR in the analysis population. | — |
Secondary
| Measure | Time frame |
|---|---|
| - OS will be defined as the time from the date of randomization to the date of death by any cause. - PFS will be evaluated using RECIST v1.1 based on Investigator assessment and will be defined as the time from the date of randomization to the date of PD or death by any cause, whichever occurs first., Assess the incidence of TEAEs, SAEs, irAEs, TEAEs leading to death, and AEs leading to discontinuation occurring while participants are on treatment or up to 90 days after the last dose of study treatment. Clinical laboratory parameters (hematology, chemistry, thyroid function, urinalysis), vital signs, ECOG performance status, ECG parameters, physical examinations, and usage of concomitant medications will be collected. | — |
Countries
France, Germany, Italy, Poland, Romania, Spain
Outcome results
None listed