Lung Cancer, Non-Small Cell
Conditions
Brief summary
PFS per RECIST 1.1 by BICR, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first, OS, defined as the time from the date of randomization to the date of death due to any cause
Detailed description
ORR, defined as the of participants with a confirmed CR or confirmed PR per RECIST 1.1 by investigator assessment, MRR, defined as the percentage of participants with a molecular response (i.e., ≥ 50% reduction in ctDNA levels relative to baseline), PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first, DOR per RECIST 1.1 by investigator assessment, defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD or death due to any cause, whichever comes first, TFST, defined as the time from the date of randomization to the date of the first subsequent anticancer therapy or death, whichever occurs first, Incidence of TEAEs, SAEs, and AESIs, Incidence of TEAEs/SAEs leading to dose withdrawals or treatment discontinuations, TTD in lung cancer symptoms defined as time from randomization to the first confirmed clinically meaningful deterioration as assessed by the NSCLC SAQ total score, TTD in physical functioning defined as time from randomization to the first confirmed clinically meaningful deterioration as assessed by the EORTC QLQ C30 physical functioning domain, Occurrence of ADA to dostarlimab and belrestotug
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL 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 |
|---|---|
| PFS per RECIST 1.1 by BICR, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first, OS, defined as the time from the date of randomization to the date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, defined as the of participants with a confirmed CR or confirmed PR per RECIST 1.1 by investigator assessment, MRR, defined as the percentage of participants with a molecular response (i.e., ≥ 50% reduction in ctDNA levels relative to baseline), PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first, DOR per RECIST 1.1 by investigator assessment, defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD or death due to any cause, whichever comes first, TFST, defined as the time from the date of randomization to the date of the first subsequent anticancer therapy or death, whichever occurs first, Incidence of TEAEs, SAEs, and AESIs, Incidence of TEAEs/SAEs leading to dose withdrawals or treatment discontinuations, TTD in lung cancer symptoms defined as time from randomization to the first confirmed clinically | — |
Countries
Belgium, Bulgaria, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
Outcome results
None listed