Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT04475939
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
666 participants
INTERVENTIONAL
2020-10-26
2026-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Participants receiving niraparib plus pembrolizumab
Eligible participants will receive niraparib along with pembrolizumab.
Niraparib
Niraparib will be administered.
Pembrolizumab
Pembrolizumab will be administered
Participants receiving placebo plus pembrolizumab
Eligible participants will receive matching placebo along with pembrolizumab.
Pembrolizumab
Pembrolizumab will be administered
Placebo
Matching placebo will be administered
Interventions
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Niraparib
Niraparib will be administered.
Pembrolizumab
Pembrolizumab will be administered
Placebo
Matching placebo will be administered
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Fullerton, California, United States
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Los Angeles, California, United States
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Lone Tree, Colorado, United States
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Norwich, Connecticut, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Newnan, Georgia, United States
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Niles, Illinois, United States
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Iowa City, Iowa, United States
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Worcester, Massachusetts, United States
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Mineola, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Sugar Land, Texas, United States
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Waco, Texas, United States
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Fairfax, Virginia, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Cipoletti Rio Negro, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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La Plata, , Argentina
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Rosario, , Argentina
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Blacktown, New South Wales, Australia
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Hobart, Tasmania, Australia
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Ballarat, Victoria, Australia
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Heidelberg, Victoria, Australia
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Belo Horizonte, , Brazil
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Cachoeiro de Itapemirim, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Uberlândia, , Brazil
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Panagyurishte, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Santiago, , Chile
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Temuco, , Chile
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Bogotá, , Colombia
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Montería, , Colombia
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Brest, , France
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Créteil, , France
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Grenoble, , France
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Lille, , France
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Paris, , France
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Paris, , France
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Rennes, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Toulon, , France
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Toulouse, , France
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Berlin, , Germany
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Bonn, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Hemer, , Germany
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Jena, , Germany
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München, , Germany
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München, , Germany
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Stuttgart, , Germany
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Velbert, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion Crete, , Greece
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Larissa, , Greece
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Neo Faliro, , Greece
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Pátrai, , Greece
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Pylaia Thessaloniki, , Greece
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Rio Patras, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Tatabánya, , Hungary
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Törökbálint, , Hungary
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Cork, , Ireland
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Dublin, , Ireland
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Avellino, , Italy
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Aviano PN, , Italy
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Bari, , Italy
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Catania, , Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Monza, , Italy
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Napoli, , Italy
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Orbassano to, , Italy
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Pisa, , Italy
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Roma, , Italy
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Verona, , Italy
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Mexico City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Puebla Puebla, , Mexico
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's-Hertogenbosch, , Netherlands
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Amersfoort, , Netherlands
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Amsterdam, , Netherlands
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Enschede, , Netherlands
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Maastricht, , Netherlands
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Utrecht, , Netherlands
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Zwolle, , Netherlands
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Drammen, , Norway
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Lrenskog, , Norway
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Oslo, , Norway
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Lima, , Peru
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Bialystok, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Iași, , Romania
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Satu Mare, , Romania
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Timișoara, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Seongnam-si, , South Korea
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Seongnam-si Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon Kyunggi-do, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Girona, , Spain
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Las Palmas de Gran Canar, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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PamplonaNavarra, , Spain
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Santander, , Spain
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Zaragoza, , Spain
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Gävle, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Lausanne, , Switzerland
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Bournemouth, , United Kingdom
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Dundee, , United Kingdom
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Middlesex, , United Kingdom
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Oxford, , United Kingdom
GSK Investigational Site
Wrexham, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2023-508443-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-002202-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
213400
Identifier Type: -
Identifier Source: org_study_id
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