Last updated: 09/26/2025 16:20:14

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung CancerZEAL-1L

GSK study ID
213400
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Up to approximately 3 years

Secondary outcomes:

PFS assessed by BICR using RECIST v 1.1 in intent to treat (ITT) population

Timeframe: Up to approximately 3 years

OS in CR/PR population

Timeframe: Up to approximately 3 years

OS in overall population

Timeframe: Up to approximately 5 years

Time to progression (TTP)

Timeframe: Up to approximately 3 years

PFS by investigator assessment using RECIST v1.1

Timeframe: Up to approximately 3 years

CNS PFS as assessed by BICR using RANO-BM

Timeframe: Up to approximately 3 years

PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status

Timeframe: Up to approximately 3 years

OS by PD-L1 status

Timeframe: Up to approximately 5 years

Time to Deterioration (TTD) in Lung Symptoms

Timeframe: Up to approximately 3 years

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)

Timeframe: 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)

Change from Baseline in HRQoL functioning and symptoms by EORTC QLQ-LC13 (Scores on a scale)

Timeframe: 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)

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

Timeframe: Up to approximately 3 years

Plasma concentrations of niraparib

Timeframe: Up to approximately 3 years

Interventions:
  • Drug: Niraparib
  • Biological/vaccine: Pembrolizumab
  • Drug: Placebo
  • Enrollment:
    666
    Primary completion date:
    2025-26-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Non-Small Cell
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2020 to February 2026
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Participant must be >=18 years of age.
    • Has a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting).
    • Has mixed small cell lung cancer or sarcomatoid variant NSCLC.
    • Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ballarat, VIC, Australia, 3350
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucuresti, Romania, 011654
    Status
    Study Complete
    Location
    GSK Investigational Site
    Craiova, Romania, 200542
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Santander, Spain, 39008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Omsk, Russia, 644013
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Germany, 13125
    Status
    Recruitment Complete
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    Actual primary completion date
    2025-26-02
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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