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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04475939
Registration number
NCT04475939
Ethics application status
Date submitted
14/07/2020
Date registered
17/07/2020
Date last updated
5/02/2024
Titles & IDs
Public title
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer
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Scientific 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)
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Secondary ID [1]
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213400
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Universal Trial Number (UTN)
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Trial acronym
ZEAL-1L
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-Small Cell
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Niraparib
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo
Experimental: Participants receiving niraparib plus pembrolizumab - Eligible participants will receive niraparib along with pembrolizumab.
Placebo Comparator: Participants receiving placebo plus pembrolizumab - Eligible participants will receive matching placebo along with pembrolizumab.
Treatment: Drugs: Niraparib
Niraparib will be administered
Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered
Treatment: Drugs: Placebo
Matching placebo will be administered
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in overall population
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Assessment method [1]
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PFS 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.
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Timepoint [1]
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Up to approximately 3 years
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Primary outcome [2]
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Overall survival (OS) in overall population
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Assessment method [2]
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OS is defined as the time from randomization to the date of death due to any cause.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [1]
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PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) population
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Assessment method [1]
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PFS 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
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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PFS assessed by BICR using RECIST v 1.1 in complete and partial response (CR/PR) population
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Assessment method [2]
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PFS 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
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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OS in NSQ population
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Assessment method [3]
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OS is defined as the time from randomization to the date of death due to any cause.
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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OS in CR/PR population
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Assessment method [4]
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OS is defined as the time from randomization to the date of death due to any cause
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Time to progression (TTP)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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PFS by investigator assessment using RECIST v1.1
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Assessment method [6]
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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.
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Timepoint [6]
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0
Up to approximately 3 years
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Secondary outcome [7]
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CNS PFS as assessed by BICR using RANO-BM
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Assessment method [7]
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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.
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Timepoint [7]
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Up to approximately 3 years
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Secondary outcome [8]
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PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status
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Assessment method [8]
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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%).
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Timepoint [8]
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Up to approximately 3 years
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Secondary outcome [9]
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OS by PD-L1 status
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Assessment method [9]
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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%).
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Time to Deterioration (TTD) in Lung Symptoms
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Assessment method [10]
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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.
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Timepoint [10]
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Up to approximately 3 years
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Secondary outcome [11]
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Change from Baseline in Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale)
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Assessment method [11]
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EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.
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Timepoint [11]
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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)
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Secondary outcome [12]
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Change from Baseline in HRQoL and symptoms by EORTC QLQ-LC13 (Scores on a scale)
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Assessment method [12]
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The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.
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Timepoint [12]
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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)
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Secondary outcome [13]
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Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
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Assessment method [13]
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AEs, SAEs and AESIs will be collected.
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Timepoint [13]
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Up to approximately 3 years
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Secondary outcome [14]
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Plasma concentrations of niraparib
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Assessment method [14]
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Blood samples will be collected to assess the plasma concentrations of niraparib.
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Timepoint [14]
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Up to approximately 3 years
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Eligibility
Key inclusion criteria
Inclusion criteria:
- 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 advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy)
or metastatic (Stage IV) or metastatic (Stage IV) NSCLC.
- Has completed at least 4 but no more than 6 cycles of standard of care first-line
platinum-based induction chemotherapy with pembrolizumab.
- Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4 to
6 cycles of standard of care first-line platinum-based induction chemotherapy with
pembrolizumab.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 12 weeks.
- Has adequate organ and bone marrow function.
- Must submit tumor specimens.
- Must be able to swallow and retain orally administered study treatment.
- A female is eligible to participate if she is not pregnant or breastfeeding, and must
follow contraceptive guidance during the treatment period and 180 days afterwards.
- A male is eligible to participate if he agrees to contraceptive guidance and refrains
from sperm donation during the intervention period and for at least 90 days after the
last dose of study treatment.
- Is able to understand the study procedures and agrees to participate in the study by
providing written informed consent. Participants must be informed that their
participation is voluntary. Participants will be required to sign a statement of
informed consent to participate in the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- 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.
- Has systolic blood pressure (BP) >140 millimeters of mercury (mmHg) or diastolic BP
>90 mmHg.
- Has any clinically significant gastrointestinal abnormalities that may alter
absorption such as malabsorption syndrome or major resection of the stomach and/or
bowels.
- Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or
radiographic signs of CNS hemorrhage.
- Has received colony-stimulating factors (granulocyte macrophage colony-stimulating
factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study
treatment.
- Has an active or previously documented autoimmune or inflammatory disorder.
- Is receiving chronic systemic steroids (prednisone >20 mg per day) other than
intermittent use of bronchodilators, inhaled steroids, or local steroid.
- Has other active concomitant malignancy that warrants systemic, biologic, or hormonal
therapy.
- Is pregnant, breastfeeding, or expecting to conceive children while receiving study
treatment and/or for up to 180 days after the last dose of study treatment.
- Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
- Has a known history of active tuberculosis.
- Has current active pneumonitis within 90 days of planned start of the study or a known
history of interstitial lung disease, drug-related pneumonitis, or radiation
pneumonitis requiring steroid treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/02/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
666
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Blacktown
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Recruitment hospital [2]
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GSK Investigational Site - Hobart
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Recruitment hospital [3]
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GSK Investigational Site - Ballarat
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Recruitment hospital [4]
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GSK Investigational Site - Heidelberg
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3350 - Ballarat
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Iowa
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Massachusetts
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New York
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North Carolina
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South Carolina
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Virginia
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-Si
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Mexico
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Ciudad De Mexico
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Mexico
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Nuevo León
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Mexico
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Mexico City
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Mexico
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Puebla
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Den Bosch
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Netherlands
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Enschede
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Netherlands
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Maastricht
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Netherlands
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Utrecht
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Netherlands
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State/province [98]
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Zwolle
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Norway
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State/province [99]
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Drammen
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Norway
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Lørenskog
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Norway
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State/province [101]
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Oslo
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Peru
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State/province [102]
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Lima
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Poland
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State/province [103]
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Bialystok
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Poland
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Lodz
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Poland
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State/province [105]
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Olsztyn
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Romania
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State/province [106]
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Bucharest
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Country [107]
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Romania
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State/province [107]
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Bucuresti
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Country [108]
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Romania
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State/province [108]
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Cluj-Napoca
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Romania
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State/province [109]
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Craiova
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Country [110]
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Romania
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State/province [110]
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Iasi
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Country [111]
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Romania
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State/province [111]
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Satu Mare
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Country [112]
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Romania
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State/province [112]
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Timisoara
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Country [113]
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Russian Federation
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State/province [113]
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Moscow
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Country [114]
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Russian Federation
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State/province [114]
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Nizhniy Novgorod
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Country [115]
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Russian Federation
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State/province [115]
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Omsk
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Country [116]
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Russian Federation
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State/province [116]
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Saint-Petersburg
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Country [117]
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Russian Federation
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State/province [117]
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St. Petersburg
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Country [118]
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Spain
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State/province [118]
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Barcelona
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Country [119]
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Spain
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State/province [119]
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Cordoba
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Country [120]
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Spain
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State/province [120]
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Girona
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Country [121]
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Spain
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State/province [121]
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La Coruña
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Country [122]
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Spain
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State/province [122]
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Las Palmas De Gran Canaria
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Spain
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State/province [123]
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Madrid
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Country [124]
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Spain
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State/province [124]
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Majadahonda (Madrid)
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Spain
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Málaga
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Spain
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State/province [126]
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Pamplona
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Country [127]
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Spain
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State/province [127]
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Santander
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Spain
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State/province [128]
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Zaragoza
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Country [129]
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Sweden
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State/province [129]
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Gävle
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Sweden
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Stockholm
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Sweden
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State/province [131]
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Uppsala
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Country [132]
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Switzerland
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State/province [132]
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Lausanne
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Country [133]
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Turkey
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State/province [133]
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Ankara
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Turkey
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State/province [134]
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Edirne
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Turkey
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State/province [135]
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Istanbul
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Country [136]
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United Kingdom
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State/province [136]
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Middlesex
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Country [137]
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United Kingdom
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State/province [137]
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Bournemouth
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Country [138]
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United Kingdom
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State/province [138]
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Dundee
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Country [139]
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United Kingdom
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Oxford
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Country [140]
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United Kingdom
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State/province [140]
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Wrexham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
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Summary
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 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04475939
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04475939
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