Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (ZEAL-1L)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer, Non-Small Cell
• Intervention / Treatment: Drug: Niraparib; Drug: Pembrolizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 666
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426AGE
    • GSK Investigational Site
  • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Cordoba, Argentina, X5004FHP
    • GSK Investigational Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
      • GSK Investigational Site
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
      • GSK Investigational Site
    • Florida, Buenos Aires, Argentina, 1602
      • GSK Investigational Site
    • La Plata, Buenos Aires, Argentina, 1900
      • GSK Investigational Site
  • Río Negro
    • Cipoletti, Río Negro, Argentina, R8324CVE
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSV
      • GSK Investigational Site
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • GSK Investigational Site
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • GSK Investigational Site
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • GSK Investigational Site
    • Heidelberg, Victoria, Australia, 3084
      • GSK Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • GSK Investigational Site
  • Edegem, Belgium, 2650
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Roeselaere, Belgium, 8800
    • GSK Investigational Site
• Brazil
  • Rio de Janeiro, Brazil, 22250-905
    • GSK Investigational Site
  • São Paulo, Brazil, 01308-901
    • GSK Investigational Site
  • São Paulo, Brazil, 01509-010
    • GSK Investigational Site
  • Espírito Santo
    • Cachoeiro Do Itapemirim, Espírito Santo, Brazil, 29308-014
      • GSK Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-022
      • GSK Investigational Site
    • Uberlândia, Minas Gerais, Brazil, 38408-150
      • GSK Investigational Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80040-170
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • GSK Investigational Site
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • GSK Investigational Site
  • Pleven, Bulgaria, 5800
    • GSK Investigational Site
  • Plovdiv, Bulgaria, 4004
    • GSK Investigational Site
  • Ruse, Bulgaria, 7002
    • GSK Investigational Site
  • Sofia, Bulgaria, 1632
    • GSK Investigational Site
• Chile
  • Región De La Araucania
    • Temuco, Región De La Araucania, Chile, 5360000
      • GSK Investigational Site
  • Región Metro De Santiago
    • Providencia, Región Metro De Santiago, Chile, 7500653
      • GSK Investigational Site
    • Santiago, Región Metro De Santiago, Chile, 7500921
      • GSK Investigational Site
• Colombia
  • Bogota, Colombia, 5600520
    • GSK Investigational Site
  • Monteria, Colombia, 230018
    • GSK Investigational Site
• France
  • Brest cedex, France, 29609
    • GSK Investigational Site
  • Créteil cedex, France, 94010
    • GSK Investigational Site
  • Grenoble cedex 9, France, 38043
    • GSK Investigational Site
  • Lille cedex, France, 59037
    • GSK Investigational Site
  • Nantes cedex 1, France, 44093
    • GSK Investigational Site
  • Paris, France, 75018
    • GSK Investigational Site
  • Paris, France, 75014
    • GSK Investigational Site
  • Rennes Cedex 9, France, 35033
    • GSK Investigational Site
  • Strasbourg, France, 67200
    • GSK Investigational Site
  • Toulon cedex, France, 83056
    • GSK Investigational Site
  • Toulouse cedex 9, France, 31059
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13125
    • GSK Investigational Site
  • Hamburg, Germany, 20251
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69126
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70376
      • GSK Investigational Site
  • Bayern
    • Gauting, Bayern, Germany, 82131
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81925
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60488
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30459
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53113
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • GSK Investigational Site
    • Hemer, Nordrhein-Westfalen, Germany, 58675
      • GSK Investigational Site
    • Velbert, Nordrhein-Westfalen, Germany, 42551
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06120
      • GSK Investigational Site
  • Schleswig-Holstein
    • Grosshansdorf, Schleswig-Holstein, Germany, 22927
      • GSK Investigational Site
  • Thueringen
    • Jena, Thueringen, Germany, 07747
      • GSK Investigational Site
• Greece
  • Athens, Greece, 115 27
    • GSK Investigational Site
  • Athens, Greece, 11528
    • GSK Investigational Site
  • Athens, Greece, 185 37
    • GSK Investigational Site
  • Athens, Greece, 12462
    • GSK Investigational Site
  • Athens, Greece, 11526
    • GSK Investigational Site
  • Athens, Greece, 15562
    • GSK Investigational Site
  • Heraklion,Crete, Greece, 71110
    • GSK Investigational Site
  • Larisa, Greece, 41110
    • GSK Investigational Site
  • Maroussi, Greece, 15125
    • GSK Investigational Site
  • N. Faliro, Greece, 185 47
    • GSK Investigational Site
  • Patra, Greece, 26500
    • GSK Investigational Site
  • Rio/Patras, Greece, 26500
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • GSK Investigational Site
  • Thessaloniki, Greece, 57001
    • GSK Investigational Site
  • Thessaloniki, Greece, 54007
    • GSK Investigational Site
  • Thessaloniki, Greece, 54645
    • GSK Investigational Site
  • Thessaloniki, Greece, 54622
    • GSK Investigational Site
• Hungary
  • Budapest, Hungary, 1083
    • GSK Investigational Site
  • Budapest, Hungary, H-1122
    • GSK Investigational Site
  • Gyöngyös, Hungary, 3200
    • GSK Investigational Site
  • Tatabánya, Hungary, 2800
    • GSK Investigational Site
  • Törökbálint, Hungary, 2045
    • GSK Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • GSK Investigational Site
• Ireland
  • Cork, Ireland, T12 DFK4
    • GSK Investigational Site
  • Dublin, Ireland, 8
    • GSK Investigational Site
• Italy
  • Campania
    • Avellino, Campania, Italy, 83100
      • GSK Investigational Site
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
  • Friuli-Venezia-Giulia
    • Aviano, Friuli-Venezia-Giulia, Italy, 33081
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00168
      • GSK Investigational Site
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20122
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20133
      • GSK Investigational Site
    • Monza, Lombardia, Italy, 20900
      • GSK Investigational Site
  • Piemonte
    • Orbassano (TO), Piemonte, Italy, 10043
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70124
      • GSK Investigational Site
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • GSK Investigational Site
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • GSK Investigational Site
    • Pisa, Toscana, Italy, 56124
      • GSK Investigational Site
  • Veneto
    • Legnago (VR), Veneto, Italy, 37045
      • GSK Investigational Site
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 463-712
    • GSK Investigational Site
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 05505
    • GSK Investigational Site
  • Seoul, Korea, Republic of, ?08308
    • GSK Investigational Site
  • Suwon-Si, Korea, Republic of, 443-721
    • GSK Investigational Site
• Mexico
  • Mexico City, Mexico, CP 14080
    • GSK Investigational Site
  • Puebla, Mexico, 72560
    • GSK Investigational Site
  • Ciudad De Mexico
    • Mexico, Ciudad De Mexico, Mexico, 03100
      • GSK Investigational Site
    • Mexico City, Ciudad De Mexico, Mexico, 06700
      • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • GSK Investigational Site
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • GSK Investigational Site
  • Amsterdam, Netherlands, 1066 CX
    • GSK Investigational Site
  • Den Bosch, Netherlands, 5223 GZ
    • GSK Investigational Site
  • Enschede, Netherlands, 7512 KZ
    • GSK Investigational Site
  • Maastricht, Netherlands, 6229 HX
    • GSK Investigational Site
  • Utrecht, Netherlands, 3543 AZ
    • GSK Investigational Site
  • Zwolle, Netherlands, 8025 AB
    • GSK Investigational Site
• Norway
  • Drammen, Norway, N-3004
    • GSK Investigational Site
  • Lørenskog, Norway, 1470
    • GSK Investigational Site
  • Oslo, Norway, N-0450
    • GSK Investigational Site
• Peru
  • Lima, Peru, Lima 34
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-540
    • GSK Investigational Site
  • Lodz, Poland, 90-338
    • GSK Investigational Site
  • Olsztyn, Poland, 10-357
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 011654
    • GSK Investigational Site
  • Bucuresti, Romania, 022328
    • GSK Investigational Site
  • Cluj-Napoca, Romania, 400015
    • GSK Investigational Site
  • Craiova, Romania, 200542
    • GSK Investigational Site
  • Iasi, Romania, 700483
    • GSK Investigational Site
  • Satu Mare, Romania, 440055
    • GSK Investigational Site
  • Timisoara, Romania, 300239
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 105 229
    • GSK Investigational Site
  • Moscow, Russian Federation, 121309
    • GSK Investigational Site
  • Nizhniy Novgorod, Russian Federation, 603081
    • GSK Investigational Site
  • Omsk, Russian Federation, 644013
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 197022
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 197758
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Cordoba, Spain, 140044
    • GSK Investigational Site
  • Girona, Spain, 17007
    • GSK Investigational Site
  • La Coruña, Spain, 15006
    • GSK Investigational Site
  • Las Palmas De Gran Canaria, Spain, 35016
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28009
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28027
    • GSK Investigational Site
  • Madrid, Spain, 28050
    • GSK Investigational Site
  • Majadahonda (Madrid), Spain, 28222
    • GSK Investigational Site
  • Málaga, Spain, 29010
    • GSK Investigational Site
  • Pamplona, Spain, 31008
    • GSK Investigational Site
  • Santander, Spain, 39008
    • GSK Investigational Site
  • Zaragoza, Spain, 50009
    • GSK Investigational Site
• Sweden
  • Gävle, Sweden, SE-801 87
    • GSK Investigational Site
  • Stockholm, Sweden, SE-171 76
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
• Switzerland
  • Lausanne, Switzerland, 1011
    • GSK Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • GSK Investigational Site
  • Ankara, Turkey, 06010
    • GSK Investigational Site
  • Ankara, Turkey, 06520
    • GSK Investigational Site
  • Edirne, Turkey, 22030
    • GSK Investigational Site
  • Istanbul, Turkey, 34662
    • GSK Investigational Site
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • GSK Investigational Site
  • Dundee, United Kingdom, DD1 9SY
    • GSK Investigational Site
  • Oxford, United Kingdom, OX3 7LJ
    • GSK Investigational Site
  • Wrexham, United Kingdom, LL13 7TD
    • GSK Investigational Site
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • GSK Investigational Site
• United States
  • California
    • Fullerton, California, United States, 92835
      • GSK Investigational Site
    • Los Angeles, California, United States, 90017
      • GSK Investigational Site
  • Colorado
    • Lone Tree, Colorado, United States, 80128
      • GSK Investigational Site
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • GSK Investigational Site
  • Florida
    • Fleming Island, Florida, United States, 32003
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • GSK Investigational Site
    • Newnan, Georgia, United States, 30265
      • GSK Investigational Site
  • Illinois
    • Niles, Illinois, United States, 60714
      • GSK Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • GSK Investigational Site
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10016
      • GSK Investigational Site
    • New York, New York, United States, 10016-4744
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • GSK Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • GSK Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37203
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78217
      • GSK Investigational Site
    • Sugar Land, Texas, United States, 77479
      • GSK Investigational Site
    • Waco, Texas, United States, 76712
      • GSK Investigational Site
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving niraparib plus pembrolizumab; Eligible participants will receive niraparib along with pembrolizumab.	Drug: Niraparib; Niraparib will be administered; Drug: Pembrolizumab; Pembrolizumab will be administered
Placebo Comparator: Participants receiving placebo plus pembrolizumab; Eligible participants will receive matching placebo along with pembrolizumab.	Drug: Pembrolizumab; Pembrolizumab will be administered; Drug: Placebo; Matching placebo will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to approximately 3 years
Overall survival (OS) in overall population	OS is defined as the time from randomization to the date of death due to any cause.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression (TTP)	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.	Up to approximately 3 years
Change from Baseline in HRQoL and symptoms by EORTC QLQ-LC13 (Scores on a scale)	The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.	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)	AEs, SAEs and AESIs will be collected.	Up to approximately 3 years
Plasma concentrations of niraparib	Blood samples will be collected to assess the plasma concentrations of niraparib.	Up to approximately 3 years
PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) population	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	Up to approximately 3 years
PFS assessed by BICR using RECIST v 1.1 in complete and partial response (CR/PR) population	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	Up to approximately 3 years
OS in NSQ population	OS is defined as the time from randomization to the date of death due to any cause.	Up to approximately 5 years
OS in CR/PR population	OS is defined as the time from randomization to the date of death due to any cause	Up to approximately 5 years
PFS by investigator assessment using RECIST v1.1	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.	Up to approximately 3 years
CNS PFS as assessed by BICR using RANO-BM	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.	Up to approximately 3 years
PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status	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%).	Up to approximately 3 years
OS by PD-L1 status	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%).	Up to approximately 5 years
Time to Deterioration (TTD) in Lung Symptoms	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.	Up to approximately 3 years
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)	EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Ramalingam SS, Thara E, Awad MM, Dowlati A, Haque B, Stinchcombe TE, Dy GK, Spigel DR, Lu S, Iyer Singh N, Tang Y, Teslenko I, Iannotti N. JASPER: Phase 2 trial of first-line niraparib plus pembrolizumab in patients with advanced non-small cell lung cancer. Cancer. 2022 Jan 1;128(1):65-74. doi: 10.1002/cncr.33885. Epub 2021 Sep 3. Erratum In: Cancer. 2023 Dec 15;129(24):3987.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): February 19, 2025

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Niraparib; Pembrolizumab; Chemotherapy; Maintenance therapy; Platinum-based
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Poly(ADP-ribose) Polymerase Inhibitors; Immune Checkpoint Inhibitors; Pembrolizumab; Niraparib
• Other Study ID Numbers: 213400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No