Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer, Non-Small Cell
- Interventions
- Registration Number
- NCT04475939
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line (SoC 1L) platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 666
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants receiving niraparib plus pembrolizumab Niraparib Eligible participants will receive niraparib along with pembrolizumab. Participants receiving niraparib plus pembrolizumab Pembrolizumab Eligible participants will receive niraparib along with pembrolizumab. Participants receiving placebo plus pembrolizumab Pembrolizumab Eligible participants will receive matching placebo along with pembrolizumab. Participants receiving placebo plus pembrolizumab Placebo Eligible participants will receive matching placebo along with pembrolizumab.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in complete and partial response (CR/PR) population Up to approximately 3 years PFS in CR/PR population is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR or death from any cause in the absence of progression, whichever occurs first.
- Secondary Outcome Measures
Name Time Method PFS assessed by BICR using RECIST v 1.1 in intent to treat (ITT) population Up to approximately 3 years PFS in the ITT Population is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR or death from any cause in the absence of progression, whichever occurs first.
OS in CR/PR population Up to approximately 3 years OS in CR/PR population defined as the time from randomization to the date of death due to any cause.
OS in overall population Up to approximately 5 years OS is defined as the time from randomization to the date of death due to any cause.
Time to progression (TTP) Up to approximately 3 years TTP in the Central nervous system (CNS) is defined as the time from the date of randomization until the earliest date of documented PD in the CNS, based on BICR assessment using response assessment in neuro-oncology brain metastases (RANO-BM) criteria.
PFS by investigator assessment using RECIST v1.1 Up to approximately 3 years PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by the Investigator using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first.
CNS PFS as assessed by BICR using RANO-BM Up to approximately 3 years PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RANO-BM criteria or until death due to any cause (whichever occurs first).
PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status Up to approximately 3 years PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PFS will be assessed by PD-L1 status (PD-L1 tumor cells \[TCs\] less than \[\<\]1% and not evaluable (NE) versus more than or equal to \[\>=\]1%).
OS by PD-L1 status Up to approximately 5 years OS is defined as the time from randomization to the date of death due to any cause. OS will be assessed by PD-L1 status (PD-L1-TCs \<1% and NE versus \>=1%).
Time to Deterioration (TTD) in Lung Symptoms Up to approximately 3 years TTD is defined as the time from randomization to meaningful deterioration as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13-item lung cancer-specific module (EORTC QLQ-LC13) questionnaire
Change from Baseline in Health-related quality of life (HRQoL), functioning and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale) Baseline, Day 1 in Cycles 1, 2, 3, 4, 5 (Each cycle is of 21 Days); thereafter every 2 cycles until 90 days after last treatment dose (up to approximately 3 years) EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.
Change from Baseline in HRQoL functioning and symptoms by EORTC QLQ-LC13 (Scores on a scale) Baseline, Day 1 in Cycles 1, 2, 3, 4, 5 (Each cycle is of 21 Days); thereafter every 2 cycles until 90 days after last treatment dose (up to approximately 3 years) The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) Up to approximately 3 years AEs, SAEs and AESIs will be collected.
Plasma concentrations of niraparib Up to approximately 3 years Blood samples will be collected to assess the plasma concentrations of niraparib.
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Wrexham, United Kingdom