metastatic NSCLC that have not progressed on a standard of care immunotherapy regimen 6 months after initiation of first line treatment., Patients with advanced
Conditions
Brief summary
Time to disease progression as measured by RECIST 1.1 or death due to any cause in each arm, where each patient is followed for progression for a maximum of 18 months after randomization.
Detailed description
Number of patients alive at 18 months after randomization of the last patient in each arm., The number and type of adverse events classified by CTCAE 5.0 grading in each arm., EQ-5D-5L, QLQ-C30 and QLQ-LC19 questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation., iMC, EQ-5D-5L questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
Sponsors
Leids Universitair Medisch Centrum (LUMC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease progression as measured by RECIST 1.1 or death due to any cause in each arm, where each patient is followed for progression for a maximum of 18 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients alive at 18 months after randomization of the last patient in each arm., The number and type of adverse events classified by CTCAE 5.0 grading in each arm., EQ-5D-5L, QLQ-C30 and QLQ-LC19 questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation., iMC, EQ-5D-5L questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation. | — |
Countries
Netherlands
Outcome results
None listed