Advanced stage NSCLC
Conditions
Brief summary
ORR, as defined by partial response (PR) and complete response (CR) at week 6, Disease control rate (DCR), as defined by stable disease (SD) and PR and CR at week 6
Detailed description
PFS, as determined using Response Evaluation Criteria in Solid Tumors (RECIST1.1) and defined as time to the development of new lesions, progression of existing lesions, or death, whichever comes first., PFS-2, as defined by the PFS on second line chemotherapy in arm 1., ORR-2, as defined by the ORR on second line chemotherapy in arm 1., Overall Survival (OS). Time frame: Baseline until death., Safety defined as the percentage of patients with adverse events. Adverse events will be defined as described in the Common Terminology Criteria for Adverse Events (CTCAE).
Interventions
DRUGPemetrexed Baxter 500 mg powder for concentrate for solution for infusion
DRUGsolution à diluer pour perfusion
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Stichting Amsterdam UMC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, as defined by partial response (PR) and complete response (CR) at week 6, Disease control rate (DCR), as defined by stable disease (SD) and PR and CR at week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, as determined using Response Evaluation Criteria in Solid Tumors (RECIST1.1) and defined as time to the development of new lesions, progression of existing lesions, or death, whichever comes first., PFS-2, as defined by the PFS on second line chemotherapy in arm 1., ORR-2, as defined by the ORR on second line chemotherapy in arm 1., Overall Survival (OS). Time frame: Baseline until death., Safety defined as the percentage of patients with adverse events. Adverse events will be defined as described in the Common Terminology Criteria for Adverse Events (CTCAE). | — |
Countries
Netherlands
Outcome results
None listed