pembrolizumab for Metastatic non-small cell lung cancer (NSCLC)

Inclusion criteria

• {"criterion_text":"- Advanced, metastatic non-small cell lung cancer UICC stage IV\n- Having received first line immunotherapy or first line (chemo)immunotherapy for 6 months ±2 weeks\n- Response or stable disease according to RECIST 1.1 as determined by imaging no older than 3 weeks at moment of randomization\n- Signed and dated informed consent.\n- ECOG PS 0-2 and fit and willing to continue treatment with first line (chemo-)immunotherapy as deemed by the treating physician"}

Exclusion criteria

• {"criterion_text":"- Other systemic anti-cancer treatment for the disease under study other than the first line (chemo-)immunotherapy\n- Any contra-indication (as per label) for treatment with immune checkpoint inhibitors"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by RECIST 1.1 (radiological assessment) or death from any cause; each patient followed for progression for a maximum of 18 months after randomization."}

Secondary endpoints

• {"endpoint_text":"- Number of patients alive at 18 months after randomization of the last patient in each arm.","definition_or_measurement_approach":"Survival status at 18 months after randomization of the last patient."}
• {"endpoint_text":"- The number and type of adverse events classified by CTCAE 5.0 grading in each arm.","definition_or_measurement_approach":"Adverse events collected and classified according to CTCAE v5.0; number and type reported per arm."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported outcomes using EQ-5D-5L, QLQ-C30 and QLQ-LC19 at baseline and every 3 months until progression (max 18 months)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Health economic measures including iMC and EQ-5D-5L collected at baseline and every 3 months until progression (max 18 months) for cost-utility and budget impact analyses."}

Netherlands

Earliest CTIS Part Ii Submission Date

26-08-2025

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

17

Number Of Sites

6

Number Of Participants

500

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands