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New drug cocktail aims to boost immune attack on lung cancer

NCT ID NCT05565378

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests several new immunotherapy drug combinations in people with advanced non-small cell lung cancer that has high levels of a protein called PD-L1. Participants have not had prior treatment for their advanced cancer. The main goal is to check the safety of these combinations, including side effects. About 351 people will take part.

What this could mean

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

Active substance
Pembrolizumab, Dostarlimab, Belrestotug, Nelistotug (immunotherapy drugs)
What this could lead to
If successful, this could lead to more effective first-line treatment options for advanced lung cancer with high PD-L1 expression.
What could go wrong
This is an early phase 2 trial with a focus on safety, so it is not yet proven to work. The combinations may cause serious side effects or not improve outcomes compared to existing therapies.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

351 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous) * No prior systemic therapy for their locally advanced or metastatic NSCLC * Provides a fresh tumor tissue sample or archival sample collected within 2 years prior to screening * PD-L1-high (TC/TPS \>= 50%) tumor * Measurable disease based on RECIST 1.1, as determined by the investigator * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Adequate Baseline organ function * Female participants of childbearing potential must use adequate contraception Exclusion Criteria: * Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC. * Had major surgery within 4 weeks or lung radiation of \>30 Gy therapy within 6 months prior to the first dose of study intervention * Received prior therapy with any immune checkpoint inhibitors * Never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime * Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years (clinical exceptions apply as per protocol) * Symptomatic, untreated, or actively progressing, brain metastases or any leptomeningeal disease (regardless of symptomatology, treatment status, or stability) * Autoimmune disease or syndrome that required systemic treatment within the past 2 years * Receiving systemic steroid therapy \<= 3 days prior to first dose of study intervention or any form of immunosuppressive medication * Received any live vaccine \<= 30 days prior to first dose of study intervention * Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis * History or evidence of cardiac abnormalities * Current unstable liver or biliary disease * Severe infection within 4 weeks prior to the first dose of study intervention * Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or hepatitis C * Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions \[e.g., pleural, pericardial, peritoneal\]) * Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention * Has a history of allogeneic tissue/stem cell transplant or solid organ transplant

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Conditions

The condition(s) this trial relates to.

lung cancer 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

    Plantation, Florida, 33322, United States

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131, United States

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404, United States

  • GSK Investigational Site

    Morgantown, West Virginia, 26506, United States

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1414DRK, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

  • GSK Investigational Site

    Florida, 1602, Argentina

  • GSK Investigational Site

    Mar del Plata, 7600, Argentina

  • GSK Investigational Site

    San Juan, J5402DIL, Argentina

  • GSK Investigational Site

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    Wilrijk, 2650, Belgium

  • GSK Investigational Site

    Barretos, 14784-400, Brazil

  • GSK Investigational Site

    Porto Alegre, 90610-000, Brazil

  • GSK Investigational Site

    São Paulo, 01246-000, Brazil

  • GSK Investigational Site

    Vitória, 29043-260, Brazil

  • GSK Investigational Site

    Oulu, 90220, Finland

  • GSK Investigational Site

    Tampere, 33520, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Vaasa, 65130, Finland

  • GSK Investigational Site

    Bordeaux, 33076, France

  • GSK Investigational Site

    Caen, 14033, France

  • GSK Investigational Site

    Marseille, 13009, France

  • GSK Investigational Site

    Quimper, 29107, France

  • GSK Investigational Site

    Strasbourg, 67091, France

  • GSK Investigational Site

    Berlin, 13125, Germany

  • GSK Investigational Site

    Essen, 45147, Germany

  • GSK Investigational Site

    Großhansdorf, 22927, Germany

  • GSK Investigational Site

    Heidelberg, 69126, Germany

  • GSK Investigational Site

    Jena, 07747, Germany

  • GSK Investigational Site

    Athens, 11528, Greece

  • GSK Investigational Site

    Haidari - Athens, 12462, Greece

  • GSK Investigational Site

    Larissa, 41110, Greece

  • GSK Investigational Site

    PapagosAthens, 115 27, Greece

  • GSK Investigational Site

    Pylaia Thessaloniki, 57001, Greece

  • GSK Investigational Site

    Thessaloniki, 54645, Greece

  • GSK Investigational Site

    Thessaloniki, 57010, Greece

  • GSK Investigational Site

    Budapest, H-1121, Hungary

  • GSK Investigational Site

    Gyöngyös, 3200, Hungary

  • GSK Investigational Site

    Tatabánya, 2800, Hungary

  • GSK Investigational Site

    Avellino, 83100, Italy

  • GSK Investigational Site

    Bergamo, 24125, Italy

  • GSK Investigational Site

    Genova, 16132, Italy

  • GSK Investigational Site

    Pisa, 57124, Italy

  • GSK Investigational Site

    Verona, 37045, Italy

  • GSK Investigational Site

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    Fukuoka, 812-8582, Japan

  • GSK Investigational Site

    Hyōgo, 673-8558, Japan

  • GSK Investigational Site

    Kanagawa, 241-8515, Japan

  • GSK Investigational Site

    Osaka, 590-0197, Japan

  • GSK Investigational Site

    Saitama, 350-1298, Japan

  • GSK Investigational Site

    Guadajalara, 44280, Mexico

  • GSK Investigational Site

    San Luis Potosí City, 78209, Mexico

  • GSK Investigational Site

    Enschede, 7512 KZ, Netherlands

  • GSK Investigational Site

    Groningen, 9728 NZ, Netherlands

  • GSK Investigational Site

    Leeuwarden, 8934 AD, Netherlands

  • GSK Investigational Site

    Utrecht, 3543 AZ, Netherlands

  • GSK Investigational Site

    Lublin, 20-954, Poland

  • GSK Investigational Site

    Prabuty, 82-550, Poland

  • GSK Investigational Site

    Siedlce, 08-110, Poland

  • GSK Investigational Site

    Gaia, 4434-502, Portugal

  • GSK Investigational Site

    Guimarães, 4835-044, Portugal

  • GSK Investigational Site

    Lisbon, 1500-650, Portugal

  • GSK Investigational Site

    Lisbon, 1998-018, Portugal

  • GSK Investigational Site

    Porto, 4200-072, Portugal

  • GSK Investigational Site

    Cape Town, 7570, South Africa

  • GSK Investigational Site

    Parktown, 2193, South Africa

  • GSK Investigational Site

    Incheon, 21565, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 03722, South Korea

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723, South Korea

  • GSK Investigational Site

    Badajoz, 06080, Spain

  • GSK Investigational Site

    Badalona, 08916, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016, Spain

  • GSK Investigational Site

    Madrid, 28027, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    PamplonaNavarra, 28027, Spain

  • GSK Investigational Site

    Valencia, 46009, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Bangkok, 10210, Thailand

  • GSK Investigational Site

    Chiang Mai, 50200, Thailand

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110, Thailand

  • GSK Investigational Site

    Khon Kaen, 40002, Thailand

  • GSK Investigational Site

    Pathum Thani, 12120, Thailand

  • GSK Investigational Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06680, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06800, Turkey (Türkiye)

  • GSK Investigational Site

    Antalya, 07070, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34214, Turkey (Türkiye)

  • GSK Investigational Site

    Abu Dhabi, 51900, United Arab Emirates

  • GSK Investigational Site

    Abu Dhabi, United Arab Emirates

  • GSK Investigational Site

    Middlesbrough, TS4 3BW, United Kingdom

  • GSK Investigational Site

    Middlesex, HA6 2RN, United Kingdom

  • GSK Investigational Site

    Wolverhampton, WV10 0QP, United Kingdom

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