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

NCT04475939 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 2134002023-508443-402020-002202-20
• Study Type: interventional
• Target: 666
• Locations: 27 countries
• Sites: 187

Brief 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).

Conditions

Lung Cancer, Non-Small Cell

Keywords

Niraparib; Pembrolizumab; Maintenance therapy; Chemotherapy; Platinum-based

Outcome Measures

Primary Outcomes (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).

  Up to 52 months

Secondary Outcomes (13)

• Progression-free Survival (PFS) Assessed by BICR - Intent-to-Treat (ITT) Population

  Up to 52 months

• Overall Survival (OS) - CR/PR Population

  Up to 52 months

• Overall Survival (OS) - ITT Population

  Up to 52 months

• Time to Progression (TTP) in the Central Nervous System (CNS) Assessed by BICR Using RANO-BM Criteria

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

• Progression-free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

  Up to 52 months

Study Arms (2)

Participants receiving niraparib plus pembrolizumab

EXPERIMENTAL

Eligible participants will receive niraparib along with pembrolizumab.

Drug: Niraparib; Biological: Pembrolizumab

Participants receiving placebo plus pembrolizumab

PLACEBO COMPARATOR

Eligible participants will receive matching placebo along with pembrolizumab.

Biological: Pembrolizumab; Drug: Placebo

Interventions

Niraparib DRUG

Niraparib will be administered.

Participants receiving niraparib plus pembrolizumab

Pembrolizumab BIOLOGICAL

Pembrolizumab will be administered

Participants receiving niraparib plus pembrolizumab; Participants receiving placebo plus pembrolizumab

Placebo DRUG

Matching placebo will be administered

Participants receiving placebo plus pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (187)

GSK Investigational Site

Fullerton, California, 92835, United States

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GSK Investigational Site

Los Angeles, California, 90017, United States

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GSK Investigational Site

Lone Tree, Colorado, 80128, United States

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Norwich, Connecticut, 06360, United States

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Tallahassee, Florida, 32003, United States

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Atlanta, Georgia, 30322, United States

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Newnan, Georgia, 30265, United States

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Niles, Illinois, 60714, United States

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Iowa City, Iowa, 52242, United States

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Worcester, Massachusetts, 01655, United States

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Mineola, New York, 10016, United States

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New York, New York, 10016-4744, United States

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Charlotte, North Carolina, 28207, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Chattanooga, Tennessee, 37404, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75246, United States

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San Antonio, Texas, 78217, United States

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Sugar Land, Texas, 77479, United States

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Waco, Texas, 76712, United States

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Fairfax, Virginia, 22031, United States

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Buenos Aires, C1125ABD, Argentina

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Buenos Aires, C1426ABP, Argentina

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Cipoletti Rio Negro, R8324CVE, Argentina

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Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina

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Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

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Córdoba, X5004FHP, Argentina

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Florida, 1602, Argentina

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La Plata, 1900, Argentina

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Rosario, S2000DSV, Argentina

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Blacktown, New South Wales, 2148, Australia

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Hobart, Tasmania, 7000, Australia

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Ballarat, Victoria, 3350, Australia

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Heidelberg, Victoria, 3084, Australia

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Belo Horizonte, 30110-022, Brazil

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Cachoeiro de Itapemirim, 29308-014, Brazil

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Curitiba, 80040-170, Brazil

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Porto Alegre, 90610-000, Brazil

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Rio de Janeiro, 22250-905, Brazil

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São Paulo, 01308-901, Brazil

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Uberlândia, 38408-150, Brazil

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Panagyurishte, 4500, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4004, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1632, Bulgaria

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Santiago, 7500653, Chile

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Temuco, 5360000, Chile

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Bogotá, 5600520, Colombia

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Montería, 230018, Colombia

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Brest, 29609, France

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Créteil, 94010, France

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Grenoble, 38043, France

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Lille, 59037, France

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Paris, 75014, France

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Paris, 75018, France

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Rennes, 35033, France

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Saint-Herblain, 44093, France

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Strasbourg, 67200, France

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Toulon, 83056, France

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Toulouse, 31059, France

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GSK Investigational Site

Berlin, 13125, Germany

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Bonn, 53113, Germany

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Essen, 45147, Germany

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Frankfurt, 60488, Germany

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Gauting, 82131, Germany

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Großhansdorf, 22927, Germany

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Halle, 06120, Germany

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Hamburg, 20251, Germany

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Hanover, 30459, Germany

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Heidelberg, 69126, Germany

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Hemer, 58675, Germany

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Jena, 07747, Germany

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München, 80336, Germany

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München, 81925, Germany

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Stuttgart, 70376, Germany

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Velbert, 42551, Germany

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Athens, 115 27, Greece

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Athens, 11526, Greece

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GSK Investigational Site

Athens, 11528, Greece

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Athens, 12462, Greece

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Athens, 15125, Greece

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Athens, 15562, Greece

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Athens, 185 37, Greece

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Heraklion Crete, 71110, Greece

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Larissa, 41110, Greece

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Neo Faliro, 185 47, Greece

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Pátrai, 26500, Greece

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Pylaia Thessaloniki, 57001, Greece

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Rio Patras, 26500, Greece

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Thessaloniki, 54007, Greece

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Thessaloniki, 54622, Greece

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Thessaloniki, 54645, Greece

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Thessaloniki, 57010, Greece

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Budapest, 1083, Hungary

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Budapest, H-1122, Hungary

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Gyöngyös, 3200, Hungary

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Tatabánya, 2800, Hungary

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Törökbálint, 2045, Hungary

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Cork, T12 DFK4, Ireland

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Dublin, 8, Ireland

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Avellino, 83100, Italy

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Aviano PN, 33081, Italy

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Bari, 70124, Italy

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Catania, 95123, Italy

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Florence, 50134, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Monza, 20900, Italy

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Naples, 80131, Italy

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Orbassano to, 10043, Italy

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Pisa, 56124, Italy

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Roma, 00168, Italy

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Verona, 37045, Italy

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Mexico City, 03100, Mexico

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Mexico City, 06700, Mexico

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Mexico City, CP 14080, Mexico

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Monterrey, 64460, Mexico

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Puebla Puebla, 72560, Mexico

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's-Hertogenbosch, 5223 GZ, Netherlands

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Amersfoort, 3813 TZ, Netherlands

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Amsterdam, 1066 CX, Netherlands

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Enschede, 7512 KZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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Utrecht, 3543 AZ, Netherlands

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Zwolle, 8025 AB, Netherlands

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Drammen, N-3004, Norway

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Lrenskog, 1470, Norway

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Oslo, N-0450, Norway

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Lima, Lima 34, Peru

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Bialystok, 15-540, Poland

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Lodz, 90-338, Poland

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Olsztyn, 10-357, Poland

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Bucharest, 011654, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Craiova, 200542, Romania

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Iași, 700483, Romania

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Satu Mare, 440055, Romania

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Timișoara, 300239, Romania

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Moscow, 105 229, Russia

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Moscow, 121309, Russia

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Nizhny Novgorod, 603081, Russia

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Omsk, 644013, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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GSK Investigational Site

Seongnam-si, 463-712, South Korea

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Seongnam-si Gyeonggi-do, 13620, South Korea

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GSK Investigational Site

Seoul, 05505, South Korea

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GSK Investigational Site

Seoul, 08308, South Korea

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GSK Investigational Site

Suwon Kyunggi-do, 443-721, South Korea

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GSK Investigational Site

A Coruña, 15006, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Córdoba, 140044, Spain

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Girona, 17007, Spain

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Las Palmas de Gran Canar, 35016, Spain

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Madrid, 28009, Spain

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Madrid, 28027, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Madrid, 28050, Spain

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Madrid, 28222, Spain

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Málaga, 29010, Spain

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PamplonaNavarra, 31008, Spain

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Santander, 39008, Spain

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GSK Investigational Site

Zaragoza, 50009, Spain

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Gävle, SE-801 87, Sweden

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Stockholm, SE-171 76, Sweden

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Uppsala, SE-751 85, Sweden

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Lausanne, 1011, Switzerland

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Ankara, 06010, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Ankara, 06520, Turkey (Türkiye)

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Edirne, 22030, Turkey (Türkiye)

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Istanbul, 34662, Turkey (Türkiye)

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Bournemouth, BH7 7DW, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Middlesex, HA6 2RN, United Kingdom

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Oxford, OX3 7LJ, United Kingdom

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Wrexham, LL13 7TD, United Kingdom

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Related Publications (1)

• 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.

  PMID: 34478166 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

niraparib; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participant Investigator study staff and the Sponsor study team will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: October 26, 2020
• Primary Completion: February 26, 2025
• Study Completion: March 23, 2026
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

RU (6); GR (17); AU (4); RO (7); ES (17); AR (9); US (21); CH (1); CL (2); NL (7); TU (5); CO (2); ME (5); BE (4); PE (1); FR (11); GB (5); BU (5); KR (5); PL (3); DE (16); SE (3); IT (14); IE (2); BR (7); HU (5); NO (3)