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New combo aims to keep lung cancer at bay after chemo

NCT ID NCT04475939

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding niraparib (a drug that interferes with cancer cell repair) to pembrolizumab (an immunotherapy) helps keep advanced non-small cell lung cancer from progressing. The study enrolled 666 adults whose cancer had stabilized or shrunk after initial platinum-based chemotherapy plus pembrolizumab. Participants were randomly assigned to receive either niraparib plus pembrolizumab or a placebo plus pembrolizumab as ongoing maintenance therapy. The main goals were to see if the combination improved the time until cancer worsened or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
niraparib and pembrolizumab
What this could lead to
If successful, this combination could help keep advanced lung cancer from growing back longer after initial treatment, potentially improving survival.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. Adding niraparib may increase side effects like low blood counts or fatigue, and it may not improve outcomes over pembrolizumab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

666 people

The number who actually took part.

Started

Oct 2020

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer (non-small cell)

Contacts and locations

Locations

  • GSK Investigational Site

    Fullerton, California, 92835, United States

  • GSK Investigational Site

    Los Angeles, California, 90017, United States

  • GSK Investigational Site

    Lone Tree, Colorado, 80128, United States

  • GSK Investigational Site

    Norwich, Connecticut, 06360, United States

  • GSK Investigational Site

    Tallahassee, Florida, 32003, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30322, United States

  • GSK Investigational Site

    Newnan, Georgia, 30265, United States

  • GSK Investigational Site

    Niles, Illinois, 60714, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    Worcester, Massachusetts, 01655, United States

  • GSK Investigational Site

    Mineola, New York, 10016, United States

  • GSK Investigational Site

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

  • GSK Investigational Site

    Charlotte, North Carolina, 28207, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212, United States

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    San Antonio, Texas, 78217, United States

  • GSK Investigational Site

    Sugar Land, Texas, 77479, United States

  • GSK Investigational Site

    Waco, Texas, 76712, United States

  • GSK Investigational Site

    Fairfax, Virginia, 22031, United States

  • GSK Investigational Site

    Buenos Aires, C1125ABD, Argentina

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

  • GSK Investigational Site

    Córdoba, X5004FHP, Argentina

  • GSK Investigational Site

    Florida, 1602, Argentina

  • GSK Investigational Site

    La Plata, 1900, Argentina

  • GSK Investigational Site

    Rosario, S2000DSV, Argentina

  • GSK Investigational Site

    Blacktown, New South Wales, 2148, Australia

  • GSK Investigational Site

    Hobart, Tasmania, 7000, Australia

  • GSK Investigational Site

    Ballarat, Victoria, 3350, Australia

  • GSK Investigational Site

    Heidelberg, Victoria, 3084, Australia

  • GSK Investigational Site

    Brussels, 1200, Belgium

  • GSK Investigational Site

    Edegem, 2650, Belgium

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Roeselare, 8800, Belgium

  • GSK Investigational Site

    Belo Horizonte, 30110-022, Brazil

  • GSK Investigational Site

    Cachoeiro de Itapemirim, 29308-014, Brazil

  • GSK Investigational Site

    Curitiba, 80040-170, Brazil

  • GSK Investigational Site

    Porto Alegre, 90610-000, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 22250-905, Brazil

  • GSK Investigational Site

    São Paulo, 01308-901, Brazil

  • GSK Investigational Site

    Uberlândia, 38408-150, Brazil

  • GSK Investigational Site

    Panagyurishte, 4500, Bulgaria

  • GSK Investigational Site

    Pleven, 5800, Bulgaria

  • GSK Investigational Site

    Plovdiv, 4004, Bulgaria

  • GSK Investigational Site

    Rousse, 7002, Bulgaria

  • GSK Investigational Site

    Sofia, 1632, Bulgaria

  • GSK Investigational Site

    Santiago, 7500653, Chile

  • GSK Investigational Site

    Santiago, 7500921, Chile

  • GSK Investigational Site

    Temuco, 5360000, Chile

  • GSK Investigational Site

    Bogotá, 5600520, Colombia

  • GSK Investigational Site

    Montería, 230018, Colombia

  • GSK Investigational Site

    Brest, 29609, France

  • GSK Investigational Site

    Créteil, 94010, France

  • GSK Investigational Site

    Grenoble, 38043, France

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Paris, 75014, France

  • GSK Investigational Site

    Paris, 75018, France

  • GSK Investigational Site

    Rennes, 35033, France

  • GSK Investigational Site

    Saint-Herblain, 44093, France

  • GSK Investigational Site

    Strasbourg, 67200, France

  • GSK Investigational Site

    Toulon, 83056, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Berlin, 13125, Germany

  • GSK Investigational Site

    Bonn, 53113, Germany

  • GSK Investigational Site

    Essen, 45147, Germany

  • GSK Investigational Site

    Frankfurt, 60488, Germany

  • GSK Investigational Site

    Gauting, 82131, Germany

  • GSK Investigational Site

    Großhansdorf, 22927, Germany

  • GSK Investigational Site

    Halle, 06120, Germany

  • GSK Investigational Site

    Hamburg, 20251, Germany

  • GSK Investigational Site

    Hanover, 30459, Germany

  • GSK Investigational Site

    Heidelberg, 69126, Germany

  • GSK Investigational Site

    Hemer, 58675, Germany

  • GSK Investigational Site

    Jena, 07747, Germany

  • GSK Investigational Site

    München, 80336, Germany

  • GSK Investigational Site

    München, 81925, Germany

  • GSK Investigational Site

    Stuttgart, 70376, Germany

  • GSK Investigational Site

    Velbert, 42551, Germany

  • GSK Investigational Site

    Athens, 115 27, Greece

  • GSK Investigational Site

    Athens, 11526, Greece

  • GSK Investigational Site

    Athens, 11528, Greece

  • GSK Investigational Site

    Athens, 12462, Greece

  • GSK Investigational Site

    Athens, 15125, Greece

  • GSK Investigational Site

    Athens, 15562, Greece

  • GSK Investigational Site

    Athens, 185 37, Greece

  • GSK Investigational Site

    Heraklion Crete, 71110, Greece

  • GSK Investigational Site

    Larissa, 41110, Greece

  • GSK Investigational Site

    Neo Faliro, 185 47, Greece

  • GSK Investigational Site

    Pátrai, 26500, Greece

  • GSK Investigational Site

    Pylaia Thessaloniki, 57001, Greece

  • GSK Investigational Site

    Rio Patras, 26500, Greece

  • GSK Investigational Site

    Thessaloniki, 54007, Greece

  • GSK Investigational Site

    Thessaloniki, 54622, Greece

  • GSK Investigational Site

    Thessaloniki, 54645, Greece

  • GSK Investigational Site

    Thessaloniki, 57010, Greece

  • GSK Investigational Site

    Budapest, 1083, Hungary

  • GSK Investigational Site

    Budapest, H-1122, Hungary

  • GSK Investigational Site

    Gyöngyös, 3200, Hungary

  • GSK Investigational Site

    Tatabánya, 2800, Hungary

  • GSK Investigational Site

    Törökbálint, 2045, Hungary

  • GSK Investigational Site

    Cork, T12 DFK4, Ireland

  • GSK Investigational Site

    Dublin, 8, Ireland

  • GSK Investigational Site

    Avellino, 83100, Italy

  • GSK Investigational Site

    Aviano PN, 33081, Italy

  • GSK Investigational Site

    Bari, 70124, Italy

  • GSK Investigational Site

    Catania, 95123, Italy

  • GSK Investigational Site

    Florence, 50134, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Monza, 20900, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Orbassano to, 10043, Italy

  • GSK Investigational Site

    Pisa, 56124, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Verona, 37045, Italy

  • GSK Investigational Site

    Mexico City, 03100, Mexico

  • GSK Investigational Site

    Mexico City, 06700, Mexico

  • GSK Investigational Site

    Mexico City, CP 14080, Mexico

  • GSK Investigational Site

    Monterrey, 64460, Mexico

  • GSK Investigational Site

    Puebla Puebla, 72560, Mexico

  • GSK Investigational Site

    's-Hertogenbosch, 5223 GZ, Netherlands

  • GSK Investigational Site

    Amersfoort, 3813 TZ, Netherlands

  • GSK Investigational Site

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    Enschede, 7512 KZ, Netherlands

  • GSK Investigational Site

    Maastricht, 6229 HX, Netherlands

  • GSK Investigational Site

    Utrecht, 3543 AZ, Netherlands

  • GSK Investigational Site

    Zwolle, 8025 AB, Netherlands

  • GSK Investigational Site

    Drammen, N-3004, Norway

  • GSK Investigational Site

    Lrenskog, 1470, Norway

  • GSK Investigational Site

    Oslo, N-0450, Norway

  • GSK Investigational Site

    Lima, Lima 34, Peru

  • GSK Investigational Site

    Bialystok, 15-540, Poland

  • GSK Investigational Site

    Lodz, 90-338, Poland

  • GSK Investigational Site

    Olsztyn, 10-357, Poland

  • GSK Investigational Site

    Bucharest, 011654, Romania

  • GSK Investigational Site

    Bucharest, 022328, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400015, Romania

  • GSK Investigational Site

    Craiova, 200542, Romania

  • GSK Investigational Site

    Iași, 700483, Romania

  • GSK Investigational Site

    Satu Mare, 440055, Romania

  • GSK Investigational Site

    Timișoara, 300239, Romania

  • GSK Investigational Site

    Moscow, 105 229, Russia

  • GSK Investigational Site

    Moscow, 121309, Russia

  • GSK Investigational Site

    Nizhny Novgorod, 603081, Russia

  • GSK Investigational Site

    Omsk, 644013, Russia

  • GSK Investigational Site

    Saint Petersburg, 197022, Russia

  • GSK Investigational Site

    Saint Petersburg, 197758, Russia

  • GSK Investigational Site

    Seongnam-si, 463-712, South Korea

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Seoul, 08308, South Korea

  • GSK Investigational Site

    Suwon Kyunggi-do, 443-721, South Korea

  • GSK Investigational Site

    A Coruña, 15006, Spain

  • GSK Investigational Site

    Barcelona, 08025, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Córdoba, 140044, Spain

  • GSK Investigational Site

    Girona, 17007, Spain

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016, Spain

  • GSK Investigational Site

    Madrid, 28009, Spain

  • GSK Investigational Site

    Madrid, 28027, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Madrid, 28050, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    PamplonaNavarra, 31008, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Gävle, SE-801 87, Sweden

  • GSK Investigational Site

    Stockholm, SE-171 76, Sweden

  • GSK Investigational Site

    Uppsala, SE-751 85, Sweden

  • GSK Investigational Site

    Lausanne, 1011, Switzerland

  • GSK Investigational Site

    Ankara, 06010, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06100, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06520, Turkey (Türkiye)

  • GSK Investigational Site

    Edirne, 22030, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34662, Turkey (Türkiye)

  • GSK Investigational Site

    Bournemouth, BH7 7DW, United Kingdom

  • GSK Investigational Site

    Dundee, DD1 9SY, United Kingdom

  • GSK Investigational Site

    Middlesex, HA6 2RN, United Kingdom

  • GSK Investigational Site

    Oxford, OX3 7LJ, United Kingdom

  • GSK Investigational Site

    Wrexham, LL13 7TD, United Kingdom

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