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ACTIVE NOT RECRUITING

NCT04475939

PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line (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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

666

Start Date

2020-10-26

Completion Date

2026-03-06

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Lung Cancer, Non-Small Cell

Interventions

DRUG

Niraparib

Niraparib will be administered.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered

DRUG

Placebo

Matching placebo will be administered

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.

Locations (189)

GSK Investigational Site

Fullerton, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Lone Tree, Colorado, United States

GSK Investigational Site

Norwich, Connecticut, United States

GSK Investigational Site

Tallahassee, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Newnan, Georgia, United States

GSK Investigational Site

Niles, Illinois, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Worcester, Massachusetts, United States

GSK Investigational Site

Mineola, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Chattanooga, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Sherman, Texas, United States

GSK Investigational Site

Sugar Land, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

Fairfax, Virginia, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Cipoletti Rio Negro, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Florida, Argentina

GSK Investigational Site

La Plata, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Blacktown, New South Wales, Australia

GSK Investigational Site

Hobart, Tasmania, Australia

GSK Investigational Site

Ballarat, Victoria, Australia

GSK Investigational Site

Heidelberg, Victoria, Australia

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Edegem, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Roeselare, Belgium

GSK Investigational Site

Belo Horizonte, Brazil

GSK Investigational Site

Cachoeiro de Itapemirim, Brazil

GSK Investigational Site

Curitiba, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Rio de Janeiro, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Uberlândia, Brazil

GSK Investigational Site

Panagyurishte, Bulgaria

GSK Investigational Site

Pleven, Bulgaria

GSK Investigational Site

Plovdiv, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Santiago, Chile

GSK Investigational Site

Temuco, Chile

GSK Investigational Site

Bogotá, Colombia

GSK Investigational Site

Montería, Colombia

GSK Investigational Site

Brest, France

GSK Investigational Site

Créteil, France

GSK Investigational Site

Grenoble, France

GSK Investigational Site

Lille, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Rennes, France

GSK Investigational Site

Saint-Herblain, France

GSK Investigational Site

Strasbourg, France

GSK Investigational Site

Toulon, France

GSK Investigational Site

Toulouse, France

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Bonn, Germany

GSK Investigational Site

Essen, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Gauting, Germany

GSK Investigational Site

Großhansdorf, Germany

GSK Investigational Site

Halle, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Hanover, Germany

GSK Investigational Site

Heidelberg, Germany

GSK Investigational Site

Hemer, Germany

GSK Investigational Site

Jena, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Stuttgart, Germany

GSK Investigational Site

Velbert, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Heraklion Crete, Greece

GSK Investigational Site

Larissa, Greece

GSK Investigational Site

Neo Faliro, Greece

GSK Investigational Site

Pátrai, Greece

GSK Investigational Site

Pylaia Thessaloniki, Greece

GSK Investigational Site

Rio Patras, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Gyöngyös, Hungary

GSK Investigational Site

Tatabánya, Hungary

GSK Investigational Site

Törökbálint, Hungary

GSK Investigational Site

Cork, Ireland

GSK Investigational Site

Dublin, Ireland

GSK Investigational Site

Avellino, Italy

GSK Investigational Site

Aviano PN, Italy

GSK Investigational Site

Bari, Italy

GSK Investigational Site

Catania, Italy

GSK Investigational Site

Florence, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Monza, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Orbassano to, Italy

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Verona, Italy

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

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Mexico City, Mexico

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Monterrey, Mexico

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Puebla Puebla, Mexico

GSK Investigational Site

's-Hertogenbosch, Netherlands

GSK Investigational Site

Amersfoort, Netherlands

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

Enschede, Netherlands

GSK Investigational Site

Maastricht, Netherlands

GSK Investigational Site

Utrecht, Netherlands

GSK Investigational Site

Zwolle, Netherlands

GSK Investigational Site

Drammen, Norway

GSK Investigational Site

Lrenskog, Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Bialystok, Poland

GSK Investigational Site

Lodz, Poland

GSK Investigational Site

Olsztyn, Poland

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Cluj-Napoca, Romania

GSK Investigational Site

Craiova, Romania

GSK Investigational Site

Iași, Romania

GSK Investigational Site

Satu Mare, Romania

GSK Investigational Site

Timișoara, Romania

GSK Investigational Site

Moscow, Russia

GSK Investigational Site

Moscow, Russia

GSK Investigational Site

Nizhny Novgorod, Russia

GSK Investigational Site

Omsk, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Seongnam-si, South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Kyunggi-do, South Korea

GSK Investigational Site

A Coruña, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Girona, Spain

GSK Investigational Site

Las Palmas de Gran Canar, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

PamplonaNavarra, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Gävle, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Lausanne, Switzerland

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Edirne, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Bournemouth, United Kingdom

GSK Investigational Site

Dundee, United Kingdom

GSK Investigational Site

Middlesex, United Kingdom

GSK Investigational Site

Oxford, United Kingdom

GSK Investigational Site

Wrexham, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (189)