AzTrials
AzTrials

Lung Cancer, Non-Small CellPhase 3ZEAL-1LNCT04475939

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer

A Phase 3 study testing Niraparib and Pembrolizumab in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 188 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
Niraparib and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
666 participants
Where
188 sitesin 27 countries
Study dates
26 Oct 2020to 23 Mar 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

188 sites in 27 countries.

188 sites in 27 countries

United States21 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30322

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Fairfax, Virginia, 22031

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Lone Tree, Colorado, 80128

  • GSK Investigational Site

    Los Angeles, California, 90017

  • GSK Investigational Site

    Mineola, New York, 10016

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New York, New York, 10016-4744

  • GSK Investigational Site

    Newnan, Georgia, 30265

  • GSK Investigational Site

    Niles, Illinois, 60714

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    San Antonio, Texas, 78217

  • GSK Investigational Site

    Sugar Land, Texas, 77479

  • GSK Investigational Site

    Tallahassee, Florida, 32003

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Worcester, Massachusetts, 01655

Other trials in United States

Greece17 sites

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 11526

  • GSK Investigational Site

    Athens, 11528

  • GSK Investigational Site

    Athens, 12462

  • GSK Investigational Site

    Athens, 15125

  • GSK Investigational Site

    Athens, 15562

  • GSK Investigational Site

    Athens, 185 37

  • GSK Investigational Site

    Heraklion Crete, 71110

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    Neo Faliro, 185 47

  • GSK Investigational Site

    Pátrai, 26500

  • GSK Investigational Site

    Pylaia Thessaloniki, 57001

  • GSK Investigational Site

    Rio Patras, 26500

  • GSK Investigational Site

    Thessaloniki, 54007

  • GSK Investigational Site

    Thessaloniki, 54622

  • GSK Investigational Site

    Thessaloniki, 54645

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Spain17 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Córdoba, 140044

  • GSK Investigational Site

    Girona, 17007

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016

  • GSK Investigational Site

    Madrid, 28009

  • GSK Investigational Site

    Madrid, 28027

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Madrid, 28222

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    PamplonaNavarra, 31008

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Germany16 sites

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Bonn, 53113

  • GSK Investigational Site

    Essen, 45147

  • GSK Investigational Site

    Frankfurt, 60488

  • GSK Investigational Site

    Gauting, 82131

  • GSK Investigational Site

    Großhansdorf, 22927

  • GSK Investigational Site

    Halle, 06120

  • GSK Investigational Site

    Hamburg, 20251

  • GSK Investigational Site

    Hanover, 30459

  • GSK Investigational Site

    Heidelberg, 69126

  • GSK Investigational Site

    Hemer, 58675

  • GSK Investigational Site

    Jena, 07747

  • GSK Investigational Site

    München, 80336

  • GSK Investigational Site

    München, 81925

  • GSK Investigational Site

    Stuttgart, 70376

  • GSK Investigational Site

    Velbert, 42551

Other trials in Germany

Italy14 sites

  • GSK Investigational Site

    Avellino, 83100

  • GSK Investigational Site

    Aviano PN, 33081

  • GSK Investigational Site

    Bari, 70124

  • GSK Investigational Site

    Catania, 95123

  • GSK Investigational Site

    Florence, 50134

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Milan, 20133

  • GSK Investigational Site

    Monza, 20900

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Orbassano to, 10043

  • GSK Investigational Site

    Pisa, 56124

  • GSK Investigational Site

    Roma, 00168

  • GSK Investigational Site

    Verona, 37045

Other trials in Italy

France11 sites

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Paris, 75014

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Saint-Herblain, 44093

  • GSK Investigational Site

    Strasbourg, 67200

  • GSK Investigational Site

    Toulon, 83056

  • GSK Investigational Site

    Toulouse, 31059

Other trials in France

Argentina9 sites

  • GSK Investigational Site

    Buenos Aires, C1125ABD

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1012AAR

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE

  • GSK Investigational Site

    Córdoba, X5004FHP

  • GSK Investigational Site

    Florida, 1602

  • GSK Investigational Site

    La Plata, 1900

  • GSK Investigational Site

    Rosario, S2000DSV

Other trials in Argentina

Brazil7 sites

  • GSK Investigational Site

    Belo Horizonte, 30110-022

  • GSK Investigational Site

    Cachoeiro de Itapemirim, 29308-014

  • GSK Investigational Site

    Curitiba, 80040-170

  • GSK Investigational Site

    Porto Alegre, 90610-000

  • GSK Investigational Site

    Rio de Janeiro, 22250-905

  • GSK Investigational Site

    São Paulo, 01308-901

  • GSK Investigational Site

    Uberlândia, 38408-150

Other trials in Brazil

Netherlands7 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5223 GZ

  • GSK Investigational Site

    Amersfoort, 3813 TZ

  • GSK Investigational Site

    Amsterdam, 1066 CX

  • GSK Investigational Site

    Enschede, 7512 KZ

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    Utrecht, 3543 AZ

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Romania7 sites

  • GSK Investigational Site

    Bucharest, 011654

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Cluj-Napoca, 400015

  • GSK Investigational Site

    Craiova, 200542

  • GSK Investigational Site

    Iași, 700483

  • GSK Investigational Site

    Satu Mare, 440055

  • GSK Investigational Site

    Timișoara, 300239

Other trials in Romania

Russia6 sites

  • GSK Investigational Site

    Moscow, 105 229

  • GSK Investigational Site

    Moscow, 121309

  • GSK Investigational Site

    Nizhny Novgorod, 603081

  • GSK Investigational Site

    Omsk, 644013

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Bulgaria5 sites

  • GSK Investigational Site

    Panagyurishte, 4500

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4004

  • GSK Investigational Site

    Rousse, 7002

  • GSK Investigational Site

    Sofia, 1632

Other trials in Bulgaria

Hungary5 sites

  • GSK Investigational Site

    Budapest, 1083

  • GSK Investigational Site

    Budapest, H-1122

  • GSK Investigational Site

    Gyöngyös, 3200

  • GSK Investigational Site

    Tatabánya, 2800

  • GSK Investigational Site

    Törökbálint, 2045

Other trials in Hungary

Mexico5 sites

  • GSK Investigational Site

    Mexico City, 03100

  • GSK Investigational Site

    Mexico City, 06700

  • GSK Investigational Site

    Mexico City, CP 14080

  • GSK Investigational Site

    Monterrey, 64460

  • GSK Investigational Site

    Puebla Puebla, 72560

Other trials in Mexico

South Korea5 sites

  • GSK Investigational Site

    Seongnam-si, 463-712

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 08308

  • GSK Investigational Site

    Suwon Kyunggi-do, 443-721

Other trials in South Korea

Turkey (Türkiye)5 sites

  • GSK Investigational Site

    Ankara, 06010

  • GSK Investigational Site

    Ankara, 06100

  • GSK Investigational Site

    Ankara, 06520

  • GSK Investigational Site

    Edirne, 22030

  • GSK Investigational Site

    Istanbul, 34662

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • GSK Investigational Site

    Bournemouth, BH7 7DW

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Middlesex, HA6 2RN

  • GSK Investigational Site

    Oxford, OX3 7LJ

  • GSK Investigational Site

    Wrexham, LL13 7TD

Other trials in United Kingdom

Australia4 sites

  • GSK Investigational Site

    Ballarat, Victoria, 3350

  • GSK Investigational Site

    Blacktown, New South Wales, 2148

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Hobart, Tasmania, 7000

Other trials in Australia

Belgium4 sites

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Chile3 sites

  • GSK Investigational Site

    Santiago, 7500653

  • GSK Investigational Site

    Santiago, 7500921

  • GSK Investigational Site

    Temuco, 5360000

Other trials in Chile

Norway3 sites

  • GSK Investigational Site

    Drammen, N-3004

  • GSK Investigational Site

    Lrenskog, 1470

  • GSK Investigational Site

    Oslo, N-0450

Other trials in Norway

Poland3 sites

  • GSK Investigational Site

    Bialystok, 15-540

  • GSK Investigational Site

    Lodz, 90-338

  • GSK Investigational Site

    Olsztyn, 10-357

Other trials in Poland

Sweden3 sites

  • GSK Investigational Site

    Gävle, SE-801 87

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Colombia2 sites

  • GSK Investigational Site

    Bogotá, 5600520

  • GSK Investigational Site

    Montería, 230018

Other trials in Colombia

Ireland2 sites

  • GSK Investigational Site

    Cork, T12 DFK4

  • GSK Investigational Site

    Dublin, 8

Other trials in Ireland

Peru1 site

  • GSK Investigational Site

    Lima, Lima 34

Other trials in Peru

Switzerland1 site

  • GSK Investigational Site

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

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).

Being tested
Niraparib, Pembrolizumab, Placebo
Keywords
Niraparib, Pembrolizumab, Maintenance therapy, Chemotherapy, Platinum-based
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Niraparib will be administered.

  • PembrolizumabBiological

    Pembrolizumab will be administered

  • PlaceboDrug

    Matching placebo will be administered

Study groups in NCT04475939
Study groupRoleWhat they receive
Participants receiving niraparib plus pembrolizumabExperimentalEligible participants will receive niraparib along with pembrolizumab.
Receives: Drug: Niraparib; Biological: Pembrolizumab
Participants receiving placebo plus pembrolizumabPlacebo comparatorEligible participants will receive matching placebo along with pembrolizumab.
Receives: Biological: Pembrolizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to 52 months

Secondary outcomes (13)

  1. 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).

    Measured: Up to 52 months

  2. 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.

    Measured: Up to 52 months

  3. 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.

    Measured: Up to 52 months

  4. 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.

    Measured: At Month 6, 12, 18, 24, 30, 36, 42 and 48

  5. 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).

    Measured: Up to 52 months

  6. 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.

    Measured: At Month 6, 12, 18, 24, 30, 36, 42 and 48

  7. 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.

    Measured: Up to 52 months

  8. 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.

    Measured: Up to 52 months

  9. 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)

    Measured: 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)

  10. 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.

    Measured: 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)

  11. 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.

    Measured: Up to 52 months

  12. 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.

    Measured: Up to 52 months

  13. Plasma Concentrations of Niraparib

    Blood samples were collected for plasma concentrations of niraparib.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2020
  2. Study start26 Oct 2020
  3. Primary completion26 Feb 2025
  4. Study completion23 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04475939
Sponsor's protocol ID
213400
Other IDs
2023-508443-40, 2020-002202-20, 2023
Acronym
ZEAL-1L
Status last verified
Jun 2026
First submitted
14 Jul 2020
Last updated
18 Jun 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • Ramalingam SS, Velcheti V, Altan M, de Castro G Jr, Thomas M, Sanborn RE, Mazieres J, Schuler M, Isaksson J, Schenker M, Poddubskaya E, Kim YJ, Parakh S, Liu W, Neibauer MW, Aghera V, Chiu G, Peters S. Phase 3 Study of Niraparib-Plus-Pembrolizumab as Maintenance Therapy for Advanced/Metastatic Non-Small Cell Lung Cancer (ZEAL-1L). J Thorac Oncol. 2026 Jul 10:104087. doi: 10.1016/j.jtho.2026.104087. Online ahead of print.

    PubMed 42431263

  • 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.

    PubMed 34478166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib and Pembrolizumab in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 188 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, Greece, Spain, Germany, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) - Complete and Partial Response (CR/PR) Population (time frame: Up to 52 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04475939, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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