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New immune cocktail aims to outperform standard lung cancer therapy

NCT ID NCT06472076

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether combining two immune-boosting drugs (belrestotug and dostarlimab) works better than the standard treatment (pembrolizumab) for people with advanced non-small cell lung cancer that has high PD-L1 levels and hasn't been treated before. About 88 participants will receive either the new combo or the standard treatment. The main goal is to check safety and side effects.

What this could mean

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

Active substance
belrestotug and dostarlimab (immune-boosting drugs)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced non-small cell lung cancer that has high PD-L1 levels.
What could go wrong
This is an early-stage Phase 3 trial with only 88 participants, so results may not apply to everyone. Immune-related side effects are possible and could be serious.

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

88 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Aug 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: * Has a 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 * Has not received prior systemic therapy for their locally advanced or metastatic NSCLC. * Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC. * Has a PD-L1-high (Tumor cells \[TC\] ≥50%) tumor * Has measurable disease (at least 1 target lesion) based on RECIST 1.1 * Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0 or 1. * Has adequate organ function Exclusion Criteria: * Has NSCLC with a tumor that harbors any of the following molecular alterations: 1. Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy 2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy 3. 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. * Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months * Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways. * Has 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, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome. * Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease * Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. * Has received any live vaccine within 30 days prior to first dose of study intervention. * Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis. * Has symptomatic ascites, pleural effusion, or pericardial effusion. * Has active inflammatory bowel disease * Has a history of significant acute or chronic cardiac diagnosis requiring intervention/treatment in the last 6 months. * Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis. * 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

    Ocala, Florida, 34474, United States

  • GSK Investigational Site

    Honolulu, Hawaii, 96819, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40503, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40509, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68114, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Fort Worth, Texas, 76104, United States

  • GSK Investigational Site

    Olympia, Washington, 98506, United States

  • GSK Investigational Site

    Buenos Aires, 1425, Argentina

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI, Argentina

  • GSK Investigational Site

    Córdoba, 5000, Argentina

  • GSK Investigational Site

    Florida, 1602, Argentina

  • GSK Investigational Site

    Mendoza, M5500AYB, Argentina

  • GSK Investigational Site

    Rosario, S2002, Argentina

  • GSK Investigational Site

    San Miguel de Tucumán, T4000, Argentina

  • GSK Investigational Site

    Hasselt, 3500, Belgium

  • GSK Investigational Site

    Mont Gaston, 5530, Belgium

  • GSK Investigational Site

    Barretos, 14784-400, Brazil

  • GSK Investigational Site

    Belém, 66.073-005, Brazil

  • GSK Investigational Site

    CuritibaPR, 80810-050, Brazil

  • GSK Investigational Site

    Florianópolis, 88034-000, Brazil

  • GSK Investigational Site

    Fortaleza, 60336-232, Brazil

  • GSK Investigational Site

    Londrina, 86015-520, Brazil

  • GSK Investigational Site

    Porto VelhoRondOnia, 76.834-899, Brazil

  • GSK Investigational Site

    Salvador, 40414-120, Brazil

  • GSK Investigational Site

    SAo JosE Do Rio PretoSP, 15090-000, Brazil

  • GSK Investigational Site

    São Paulo, 04312903, Brazil

  • GSK Investigational Site

    Vitória, 29043-260, Brazil

  • GSK Investigational Site

    Haskovo, 6300, Bulgaria

  • GSK Investigational Site

    Plovdiv, 4004, Bulgaria

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • GSK Investigational Site

    Chengdu, 610000, China

  • GSK Investigational Site

    Hangzhou, 310006, China

  • GSK Investigational Site

    Hangzhou, China

  • GSK Investigational Site

    Hefei, 230001, China

  • GSK Investigational Site

    Nanjing, 210006, China

  • GSK Investigational Site

    Shanghai, 200030, China

  • GSK Investigational Site

    Kuopio, 70210, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Angers, 49000, France

  • GSK Investigational Site

    Boulogne-Billancourt, 92100, France

  • GSK Investigational Site

    Limoges, 87042, France

  • GSK Investigational Site

    Lorient, 56100, France

  • GSK Investigational Site

    Pessac, 33064, France

  • GSK Investigational Site

    Rennes, 35033, France

  • GSK Investigational Site

    Hamburg, 20251, Germany

  • GSK Investigational Site

    Shatin, Hong Kong

  • GSK Investigational Site

    Gokul Shirgoan, Kolhapur, 416234, India

  • GSK Investigational Site

    Apex Wellness Hospital, 422005, India

  • GSK Investigational Site

    Bangalore, 560085, India

  • GSK Investigational Site

    Belagavi, 590010, India

  • GSK Investigational Site

    Bhubaneswar, 751007, India

  • GSK Investigational Site

    Gurgaon, 122001, India

  • GSK Investigational Site

    New Delhi, 110075, India

  • GSK Investigational Site

    Aichi, 466-8560, Japan

  • GSK Investigational Site

    Ehime, 790-0024, Japan

  • GSK Investigational Site

    Fukuoka, 814-0180, Japan

  • GSK Investigational Site

    Hokkaido, 062-0931, Japan

  • GSK Investigational Site

    Hyōgo, 665-0827, Japan

  • GSK Investigational Site

    Kyoto, 612-8555, Japan

  • GSK Investigational Site

    Mie, 515-8544, Japan

  • GSK Investigational Site

    Miyagi, 981-0914, Japan

  • GSK Investigational Site

    Nagasaki, 852-8501, Japan

  • GSK Investigational Site

    Niigata, 951-8566, Japan

  • GSK Investigational Site

    Osaka, 596-8501, Japan

  • GSK Investigational Site

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    Tokyo, 162-8655, Japan

  • GSK Investigational Site

    Tottori, 683-8504, Japan

  • GSK Investigational Site

    Wakayama, 641-8510, Japan

  • GSK Investigational Site

    Guadajalara, 44280, Mexico

  • GSK Investigational Site

    La Paz BCS, 23040, Mexico

  • GSK Investigational Site

    Mexico City, 06700, Mexico

  • GSK Investigational Site

    San Luis Potosí City, 78209, Mexico

  • GSK Investigational Site

    Alkmaar, 1815 JD, Netherlands

  • GSK Investigational Site

    Enschede, 7512 KZ, Netherlands

  • GSK Investigational Site

    Panama City, Panama

  • GSK Investigational Site

    Punta Pacifica Panama City Panama, Panama

  • GSK Investigational Site

    Daegu, 41404, South Korea

  • GSK Investigational Site

    Incheon, 21565, South Korea

  • GSK Investigational Site

    Seoul, 02841, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Seoul, 08308, South Korea

  • GSK Investigational Site

    Seoul, 120-752, South Korea

  • GSK Investigational Site

    A Coruña, 15006, Spain

  • GSK Investigational Site

    Aravaca, 28013, Spain

  • GSK Investigational Site

    BaracaldoVizcaya, 48903, Spain

  • GSK Investigational Site

    Barcelona, 08003, Spain

  • GSK Investigational Site

    Barcelona, 08023, Spain

  • GSK Investigational Site

    Barcelona, 08025, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Jaén, 23007, Spain

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016, Spain

  • GSK Investigational Site

    Madrid, 28010, Spain

  • GSK Investigational Site

    Madrid, 28033, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Oviedo, 33006, Spain

  • GSK Investigational Site

    Pamplona, 31008, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Seville, 41014, Spain

  • GSK Investigational Site

    Valladolid, 47003, Spain

  • GSK Investigational Site

    Gävle, SE-801 87, Sweden

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Taipei, 23561, Taiwan

  • GSK Investigational Site

    Adana, 1120, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06560, Turkey (Türkiye)

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