Cure My Disease

Don't miss your cure!

 Log in / Sign up

New cocktail aims to outsmart lung cancer resistance

NCT ID NCT04655976

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Updated 3 times

Summary

This phase 2/3 trial is testing whether adding two immunotherapy drugs (cobolimab and dostarlimab) to standard chemotherapy (docetaxel) helps people with advanced non-small cell lung cancer live longer. The study includes about 758 participants whose cancer has worsened after prior treatments. Researchers are comparing the three-drug combo against two-drug and single-drug options to see which works best.

What this could mean

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

Active substance
cobolimab, dostarlimab, and docetaxel
What this could lead to
If successful, this combination could offer a new treatment option that extends survival for people with advanced lung cancer who have already tried standard therapies.
What could go wrong
This is still an experimental approach. The trial is large but results are not yet available, and the added benefit over existing treatments is uncertain. Side effects from combining multiple drugs may be significant.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

758 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Mar 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: * Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma. * Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody. * Participant has measurable disease. * Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy. * Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry. * Participant has an ECOG performance status score of 0 or 1. * Participant has a life expectancy of at least 3 months. * Participant has adequate Baseline organ function. * Participant has recovered from any prior treatment related toxicities. * Participant agrees to use contraception. Exclusion Criteria: * Participant has been previously treated with an anti-PD-\[L\]1 or anti-programmed death-ligand 2 (anti-PD-\[L\]2) agent that resulted in permanent discontinuation due to an AE. * Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel. * Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations. * Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) \<=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan. * Participant has received radiation to the lung that is \>30 gray (Gy) within 6 months prior to the first dose of study treatment. * Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment. * Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) \>2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) \>1.5 times ULN concomitant with alkaline phosphatase (ALP) \>2.5 times ULN; c. Bilirubin \>1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment). * Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment. * Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study. * Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies). * Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. * Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible. * Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management. * Participant has pre-existing peripheral neuropathy that is Grade \>=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria. * Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines. * Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose \<=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lung cancer, non-small cell are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

    Fountain Valley, California, 92708, United States

  • GSK Investigational Site

    Walnut Creek, California, 94596, United States

  • GSK Investigational Site

    Norwich, Connecticut, 06360, United States

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20422, United States

  • GSK Investigational Site

    Honolulu, Hawaii, 96819, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    Edgewood, Kentucky, 41017, United States

  • GSK Investigational Site

    Las Vegas, Nevada, 89144, United States

  • GSK Investigational Site

    Mineola, New York, 11501, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    White Plains, New York, 10601, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232, United States

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    Fredericksburg, Virginia, 22408, United States

  • GSK Investigational Site

    Tacoma, Washington, 98405, 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, 1425, Argentina

  • GSK Investigational Site

    Florida, 1602, Argentina

  • GSK Investigational Site

    La Rioja, F5300COE, Argentina

  • GSK Investigational Site

    Pergamino, B2700CPM, Argentina

  • GSK Investigational Site

    Rosario, S2000DBS, Argentina

  • GSK Investigational Site

    Viedma, R8500ACE, Argentina

  • GSK Investigational Site

    South Brisbane, Queensland, 4101, Australia

  • GSK Investigational Site

    Ashford, South Australia, 5037, Australia

  • GSK Investigational Site

    Hobart, Tasmania, 7000, Australia

  • GSK Investigational Site

    Ballarat, Victoria, 3350, Australia

  • GSK Investigational Site

    Melbourne, Victoria, 3004, Australia

  • GSK Investigational Site

    Mount Waverley, Victoria, 3350, Australia

  • GSK Investigational Site

    Aalst, 9300, Belgium

  • GSK Investigational Site

    Hasselt, 3500, Belgium

  • GSK Investigational Site

    Kortrijk, 8500, Belgium

  • GSK Investigational Site

    Blumenau, 89010340, Brazil

  • GSK Investigational Site

    Fortaleza, 60336-232, Brazil

  • GSK Investigational Site

    Porto Alegre, 90610000, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 22061080, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 22250-905, Brazil

  • GSK Investigational Site

    Salvador, 40170-110, Brazil

  • GSK Investigational Site

    São Paulo, 04014-002, Brazil

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7, Canada

  • GSK Investigational Site

    Oshawa, Ontario, L1G 2B9, Canada

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1, Canada

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    Helsinki, 00180, Finland

  • GSK Investigational Site

    Kuopio, 70210, Finland

  • GSK Investigational Site

    Créteil, 94010, France

  • GSK Investigational Site

    Grenoble, 38043, France

  • GSK Investigational Site

    Marseille, 13009, France

  • GSK Investigational Site

    Nice, 06189, France

  • GSK Investigational Site

    Quimper, 29107, France

  • GSK Investigational Site

    Rennes, 35033, France

  • GSK Investigational Site

    Tours, 37044, France

  • GSK Investigational Site

    Augsburg, 86156, Germany

  • GSK Investigational Site

    Bad Berka, 99437, Germany

  • GSK Investigational Site

    Berlin, 12200, Germany

  • GSK Investigational Site

    Bonn, 53113, Germany

  • GSK Investigational Site

    Cologne, 51109, Germany

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Essen, 45147, Germany

  • GSK Investigational Site

    Frankfurt, 60488, Germany

  • GSK Investigational Site

    Frankfurt, 60590, Germany

  • GSK Investigational Site

    Halle, 06120, Germany

  • GSK Investigational Site

    Heidelberg, 69126, Germany

  • GSK Investigational Site

    Karlsruhe, 76137, Germany

  • GSK Investigational Site

    München, 80336, Germany

  • GSK Investigational Site

    München, 81925, Germany

  • GSK Investigational Site

    Oldenburg, 26121, 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

    Larissa, 41100, Greece

  • GSK Investigational Site

    Pylaia Thessaloniki, 570 01, Greece

  • GSK Investigational Site

    Rio Patras, 26504, Greece

  • GSK Investigational Site

    Thessaloniki, 55236, Greece

  • GSK Investigational Site

    Thessaloniki, 57010, Greece

  • GSK Investigational Site

    Ancona, 60126, Italy

  • GSK Investigational Site

    Avellino, 83100, Italy

  • GSK Investigational Site

    Florence, 50134, 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

    Perugia, 06156, Italy

  • GSK Investigational Site

    Siena, 53100, Italy

  • GSK Investigational Site

    Kyoto, 612-8555, Japan

  • GSK Investigational Site

    Miyagi, 981-1293, Japan

  • GSK Investigational Site

    Osaka, 591-8555, Japan

  • GSK Investigational Site

    Yamaguchi, 755-0241, Japan

  • GSK Investigational Site

    Guadajalara, 44280, Mexico

  • GSK Investigational Site

    Mexico City, 03100, Mexico

  • GSK Investigational Site

    Mexico City, 03810, 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

    Amersfoort, 3813 TZ, Netherlands

  • GSK Investigational Site

    Enschede, 7512 KZ, Netherlands

  • GSK Investigational Site

    Groningen, 9713 GZ, Netherlands

  • GSK Investigational Site

    Harderwijk, 3844 DG, Netherlands

  • GSK Investigational Site

    Nijmegen, 6525 GA, Netherlands

  • GSK Investigational Site

    Utrecht, 3543 AZ, Netherlands

  • GSK Investigational Site

    Zwolle, 8025 AB, Netherlands

  • GSK Investigational Site

    Bydgoszcz, 85-796, Poland

  • GSK Investigational Site

    Gdynia, 81-519, Poland

  • GSK Investigational Site

    Lodz, 90-338, Poland

  • GSK Investigational Site

    Olsztyn, 10-357, Poland

  • GSK Investigational Site

    Piła, 64-920, Poland

  • GSK Investigational Site

    Poznan, 60-693, Poland

  • GSK Investigational Site

    Bucharest, 013812, Romania

  • GSK Investigational Site

    Craiova, 200347, Romania

  • GSK Investigational Site

    Craiova Dolj, 200385, Romania

  • GSK Investigational Site

    Otopeni, 075100, Romania

  • GSK Investigational Site

    Timișoara, 300239, Romania

  • GSK Investigational Site

    Chelyabinsk, 454048, Russia

  • GSK Investigational Site

    Moscow Region, 143423, Russia

  • GSK Investigational Site

    Pushkin, 196603, Russia

  • GSK Investigational Site

    Saint Petersburg, 197022, Russia

  • GSK Investigational Site

    Cheongju Chungcheongbuk-do, 28644, South Korea

  • GSK Investigational Site

    Daegu, 42601, South Korea

  • GSK Investigational Site

    Gyeonggi-do, 10408, South Korea

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620, South Korea

  • GSK Investigational Site

    Seoul, 03722, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Seoul, 06351, 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

    Badalona, 08916, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Burgos, 09006, Spain

  • GSK Investigational Site

    Córdoba, 140044, Spain

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28034, 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

    Valencia, 46026, Spain

  • GSK Investigational Site

    Gävle, SE-801 87, Sweden

  • GSK Investigational Site

    Stockholm, 171 64, Sweden

  • GSK Investigational Site

    Uppsala, SE-751 85, Sweden

  • GSK Investigational Site

    Taipei, 11217, Taiwan

  • GSK Investigational Site

    Dusit, 10300, 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

    Adana, 1120, Turkey (Türkiye)

  • GSK Investigational Site

    Antalya, 07020, Turkey (Türkiye)

  • GSK Investigational Site

    Izmir, 35600, Turkey (Türkiye)

  • GSK Investigational Site

    Cardiff, CF14 2TL, United Kingdom

  • GSK Investigational Site

    Edinburgh, EH4 2XU, United Kingdom

  • GSK Investigational Site

    London, SE1 9RT, United Kingdom

  • GSK Investigational Site

    London, W1G 6AD, United Kingdom

  • GSK Investigational Site

    Manchester, M20 4BX, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.