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 (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).

Study Overview

• Status: Completed
• Conditions: Lung Cancer, Non-Small Cell
• Intervention / Treatment: Drug: Placebo; Drug: Niraparib; Biological: Pembrolizumab

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

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1125ABD
    • GSK Investigational Site
  • Cipoletti Rio Negro, Argentina, R8324CVE
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
    • GSK Investigational Site
  • Córdoba, Argentina, X5004FHP
    • GSK Investigational Site
  • Florida, Argentina, 1602
    • GSK Investigational Site
  • La Plata, Argentina, 1900
    • GSK Investigational Site
  • Rosario, 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
  • Roeselare, Belgium, 8800
    • GSK Investigational Site
• Brazil
  • Belo Horizonte, Brazil, 30110-022
    • GSK Investigational Site
  • Cachoeiro de Itapemirim, Brazil, 29308-014
    • GSK Investigational Site
  • Curitiba, Brazil, 80040-170
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90610-000
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 22250-905
    • GSK Investigational Site
  • São Paulo, Brazil, 01308-901
    • GSK Investigational Site
  • Uberlândia, Brazil, 38408-150
    • GSK Investigational Site
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • GSK Investigational Site
  • Pleven, Bulgaria, 5800
    • GSK Investigational Site
  • Plovdiv, Bulgaria, 4004
    • GSK Investigational Site
  • Rousse, Bulgaria, 7002
    • GSK Investigational Site
  • Sofia, Bulgaria, 1632
    • GSK Investigational Site
• Chile
  • Santiago, Chile, 7500653
    • GSK Investigational Site
  • Temuco, Chile, 5360000
    • GSK Investigational Site
• Colombia
  • Bogotá, Colombia, 5600520
    • GSK Investigational Site
  • Montería, Colombia, 230018
    • GSK Investigational Site
• France
  • Brest, France, 29609
    • GSK Investigational Site
  • Créteil, France, 94010
    • GSK Investigational Site
  • Grenoble, France, 38043
    • GSK Investigational Site
  • Lille, France, 59037
    • GSK Investigational Site
  • Paris, France, 75018
    • GSK Investigational Site
  • Paris, France, 75014
    • GSK Investigational Site
  • Rennes, France, 35033
    • GSK Investigational Site
  • Saint-Herblain, France, 44093
    • GSK Investigational Site
  • Strasbourg, France, 67200
    • GSK Investigational Site
  • Toulon, France, 83056
    • GSK Investigational Site
  • Toulouse, France, 31059
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13125
    • GSK Investigational Site
  • Bonn, Germany, 53113
    • GSK Investigational Site
  • Essen, Germany, 45147
    • GSK Investigational Site
  • Frankfurt, Germany, 60488
    • GSK Investigational Site
  • Gauting, Germany, 82131
    • GSK Investigational Site
  • Großhansdorf, Germany, 22927
    • GSK Investigational Site
  • Halle, Germany, 06120
    • GSK Investigational Site
  • Hamburg, Germany, 20251
    • GSK Investigational Site
  • Hanover, Germany, 30459
    • GSK Investigational Site
  • Heidelberg, Germany, 69126
    • GSK Investigational Site
  • Hemer, Germany, 58675
    • GSK Investigational Site
  • Jena, Germany, 07747
    • GSK Investigational Site
  • München, Germany, 80336
    • GSK Investigational Site
  • München, Germany, 81925
    • GSK Investigational Site
  • Stuttgart, Germany, 70376
    • GSK Investigational Site
  • Velbert, Germany, 42551
    • 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
  • Athens, Greece, 15125
    • GSK Investigational Site
  • Heraklion Crete, Greece, 71110
    • GSK Investigational Site
  • Larissa, Greece, 41110
    • GSK Investigational Site
  • Neo Faliro, Greece, 185 47
    • GSK Investigational Site
  • Pylaia Thessaloniki, Greece, 57001
    • GSK Investigational Site
  • Pátrai, Greece, 26500
    • GSK Investigational Site
  • Rio Patras, Greece, 26500
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • 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
• Ireland
  • Cork, Ireland, T12 DFK4
    • GSK Investigational Site
  • Dublin, Ireland, 8
    • GSK Investigational Site
• Italy
  • Avellino, Italy, 83100
    • GSK Investigational Site
  • Aviano PN, Italy, 33081
    • GSK Investigational Site
  • Bari, Italy, 70124
    • GSK Investigational Site
  • Catania, Italy, 95123
    • GSK Investigational Site
  • Florence, Italy, 50134
    • GSK Investigational Site
  • Milan, Italy, 20132
    • GSK Investigational Site
  • Milan, Italy, 20133
    • GSK Investigational Site
  • Milan, Italy, 20122
    • GSK Investigational Site
  • Monza, Italy, 20900
    • GSK Investigational Site
  • Naples, Italy, 80131
    • GSK Investigational Site
  • Orbassano to, Italy, 10043
    • GSK Investigational Site
  • Pisa, Italy, 56124
    • GSK Investigational Site
  • Roma, Italy, 00168
    • GSK Investigational Site
  • Verona, Italy, 37045
    • GSK Investigational Site
• Mexico
  • Mexico City, Mexico, 03100
    • GSK Investigational Site
  • Mexico City, Mexico, 06700
    • GSK Investigational Site
  • Mexico City, Mexico, CP 14080
    • GSK Investigational Site
  • Monterrey, Mexico, 64460
    • GSK Investigational Site
  • Puebla Puebla, Mexico, 72560
    • GSK Investigational Site
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • GSK Investigational Site
  • Amersfoort, Netherlands, 3813 TZ
    • GSK Investigational Site
  • Amsterdam, Netherlands, 1066 CX
    • 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
  • Lrenskog, 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, 022328
    • GSK Investigational Site
  • Bucharest, Romania, 011654
    • GSK Investigational Site
  • Cluj-Napoca, Romania, 400015
    • GSK Investigational Site
  • Craiova, Romania, 200542
    • GSK Investigational Site
  • Iași, Romania, 700483
    • GSK Investigational Site
  • Satu Mare, Romania, 440055
    • GSK Investigational Site
  • Timișoara, Romania, 300239
    • GSK Investigational Site
• Russia
  • Moscow, Russia, 105 229
    • GSK Investigational Site
  • Moscow, Russia, 121309
    • GSK Investigational Site
  • Nizhny Novgorod, Russia, 603081
    • GSK Investigational Site
  • Omsk, Russia, 644013
    • GSK Investigational Site
  • Saint Petersburg, Russia, 197022
    • GSK Investigational Site
  • Saint Petersburg, Russia, 197758
    • GSK Investigational Site
• South Korea
  • Seongnam-si, South Korea, 463-712
    • GSK Investigational Site
  • Seongnam-si Gyeonggi-do, South Korea, 13620
    • GSK Investigational Site
  • Seoul, South Korea, 05505
    • GSK Investigational Site
  • Seoul, South Korea, 08308
    • GSK Investigational Site
  • Suwon Kyunggi-do, South Korea, 443-721
    • GSK Investigational Site
• Spain
  • A Coruña, Spain, 15006
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Córdoba, Spain, 140044
    • GSK Investigational Site
  • Girona, Spain, 17007
    • GSK Investigational Site
  • Las Palmas de Gran Canar, 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
  • Madrid, Spain, 28222
    • GSK Investigational Site
  • Málaga, Spain, 29010
    • GSK Investigational Site
  • PamplonaNavarra, 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 (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • GSK Investigational Site
  • Ankara, Turkey (Türkiye), 06100
    • GSK Investigational Site
  • Ankara, Turkey (Türkiye), 06520
    • GSK Investigational Site
  • Edirne, Turkey (Türkiye), 22030
    • GSK Investigational Site
  • Istanbul, Turkey (Türkiye), 34662
    • GSK Investigational Site
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • GSK Investigational Site
  • Dundee, United Kingdom, DD1 9SY
    • GSK Investigational Site
  • Middlesex, United Kingdom, HA6 2RN
    • GSK Investigational Site
  • Oxford, United Kingdom, OX3 7LJ
    • GSK Investigational Site
  • Wrexham, United Kingdom, LL13 7TD
    • 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
    • Tallahassee, 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
    • Mineola, 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
  • 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, 22031
      • 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 SoC 1L 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 SoC 1L 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.; Biological: Pembrolizumab; Pembrolizumab will be administered
Placebo Comparator: Participants receiving placebo plus pembrolizumab; Eligible participants will receive matching placebo along with pembrolizumab.	Drug: Placebo; Matching placebo will be administered; Biological: Pembrolizumab; Pembrolizumab 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) - Complete and Partial Response (CR/PR) Population	PFS is defined as the time from the date of randomization to the date of first objectively documented disease progression (PD) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).	Up to 52 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Assessed by BICR - Intent-to-Treat (ITT) Population	PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).	Up to 52 months
Overall Survival (OS) - CR/PR Population	OS is defined as the interval of time from the date of randomization to the date of death due to any cause.	Up to 52 months
Overall Survival (OS) - ITT Population	OS is defined as the interval of time from the date of randomization to the date of death due to any cause.	Up to 52 months
Time to Progression (TTP) in the Central Nervous System (CNS) Assessed by BICR Using RANO-BM Criteria	TTP in the CNS is defined as the time from the date of randomization until the earliest date of documented PD in the CNS as assessed by BICR using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. This endpoint was analysed using a cumulative incidence competing-risk analysis, and the cumulative incidence rate was reported.	At Month 6, 12, 18, 24, 30, 36, 42 and 48
Progression-free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1	PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by investigators using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).	Up to 52 months
CNS-PFS as Assessed by BICR Using RANO-BM Criteria	PFS is defined as the time from the date of randomization to the date of first radiographic progression in the CNS as determined by BICR using RANO-BM criteria or until death due to any cause (whichever occurs first). This endpoint was analysed using a cumulative incidence competing-risk analysis, and the cumulative incidence rate was reported.	At Month 6, 12, 18, 24, 30, 36, 42 and 48
Progression-free Survival (PFS) 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 objectively documented PD as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Participants were evaluated by PD-L1 status: Tumor Cells (TCs) ≥1% and TCs <1%/Not Evaluable.	Up to 52 months
Overall Survival by Programmed Cell Death-ligand 1 (PD-L1) Status	OS is defined as the interval of time from the date of randomization to the date of death due to any cause. Participants were evaluated by PD-L1 status: Tumor Cells (TCs) ≥1% and TCs <1%/Not Evaluable.	Up to 52 months
Number of Participants With Minimally Clinically Important Difference (MCID) Status in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)	The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. MCID status: Functional scales & GHS/QoL (Improved: ≥ +10; Stable: > -10 and < +10; Worsened: ≤ -10) and Symptom scales (Improved: ≤ -10; Stable: > -10 and < +10; Worsened: ≥ +10)	Baseline (Predose); Day (D) 1 of Cycle (C)2, C3, C4, C5-C67 (odd cycles only); End of Treatment (EoT, up to approx 49 months); Safety follow-up (SFU) 1 & 2 (up to approx 50 & 52 months)
Changes From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13-item Lung Cancer-specific Module (EORTC QLQ-LC13)	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, hemoptysis, dyspnea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.	Baseline (Predose); Day (D) 1 of Cycle (C)2, C3, C4, C5-C67 (odd cycles only); EoT (up to approx 49 months); Safety follow-up (SFU) 1 & 2 (up to approx 50 & 52 months)
Time to Deterioration (TTD) in EORTC Cancer Quality of Life Questionnaire LC13 (EORTC QLQ-LC13)	TTD in lung symptoms is defined as the time from randomization to first onset of ≥10 point increase from baseline with confirmation by a second adjacent ≥10 point increase in the same symptom domain for any of the three symptoms: dyspnea, chest pain, and cough, on the EORTC QLQ-LC13 were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. A longer TTD indicates a better outcome.	Up to 52 months
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AESI is any AE (serious or nonserious) that is of scientific and medical concern specific to niraparib for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is warranted. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.	Up to 52 months
Plasma Concentrations of Niraparib	Blood samples were collected for plasma concentrations of niraparib.	Cycle 1 Day 1 (pre-dose, 3 h), Cycle 1 Day 15 (pre-dose, 3 h), Cycle 2 Day 1 (pre-dose, 3 h), Cycle 4 Day 1 (pre-dose), Cycle 7 Day 1 (pre-dose), and End of Treatment (pre-dose); up to approximately 49 months

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.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): March 23, 2026

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): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Niraparib; Pembrolizumab; Chemotherapy; Maintenance therapy; Platinum-based
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Poly(ADP-ribose) Polymerase Inhibitors; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; pembrolizumab; niraparib
• Other Study ID Numbers: 213400; 2023-508443-40 (Registry Identifier: CTIS); 2020-002202-20 (EudraCT Number)

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.: Yes