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New immunotherapy cocktail aims to boost lung cancer survival

NCT ID NCT04623775

Disease control Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding relatlimab to the standard immunotherapy nivolumab plus chemotherapy could shrink tumors better in people with advanced or recurrent non-small cell lung cancer. About 468 participants received either the two-immunotherapy combo with chemo or nivolumab with chemo. The study looked at safety and tumor response rates.

What this could mean

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

Active substance
relatlimab and nivolumab (immunotherapy drugs) plus chemotherapy
What this could lead to
If it works, this could offer a more effective first-line treatment option for advanced or recurrent non-small cell lung cancer.
What could go wrong
This is a phase 2 trial, so results are still preliminary. Adding another immunotherapy may increase side effects without improving outcomes.

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

468 people

The number who actually took part.

Started

Feb 2021

Finished

May 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 * Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization. * Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria. * No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease. Exclusion Criteria * Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy. * Untreated CNS metastases. * Leptomeningeal metastases (carcinomatous meningitis). * Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease). * Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Other protocol-defined Inclusion/Exclusion criteria apply.

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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.

Metastatic non-small cell lung cancer Non-small cell lung cancer Recurrent non small cell lung cancer

Contacts and locations

Locations

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045, Russia

  • FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus

    Saint Petersburg, 197376, Russia

  • LLC Eurocityclinic

    Saint Petersburg, 197022, Russia

  • Local Institution - 0001

    Tyler, Texas, 75701, United States

  • Local Institution - 0002

    Louisville, Kentucky, 40241, United States

  • Local Institution - 0006

    Saint-Mandé, 94160, France

  • Local Institution - 0007

    Dijon, 21 000, France

  • Local Institution - 0008

    Rennes, Ille-Et-Vilaine, 35000, France

  • Local Institution - 0009

    Catania, 95125, Italy

  • Local Institution - 0011

    Port Saint Lucie, Florida, 34952, United States

  • Local Institution - 0012

    Craiova, Jud. Dolj, 200094, Romania

  • Local Institution - 0013

    San Pedro Garza García, Nuevo León, 66220, Mexico

  • Local Institution - 0014

    Cuiudad Autonoma de Buenos Aires, Distrito Federal, C1430EGF, Argentina

  • Local Institution - 0015

    Basel, 4031, Switzerland

  • Local Institution - 0016

    Santiago, Santiago Metropolitan, 7500921, Chile

  • Local Institution - 0017

    Craiova, Dolj, 200385, Romania

  • Local Institution - 0019

    Siena, 53100, Italy

  • Local Institution - 0020

    Toluca, State of Mexico, 50090, Mexico

  • Local Institution - 0021

    Buenos Aires, Distrito Federal, C1426, Argentina

  • Local Institution - 0023

    Dublin, 00009, Ireland

  • Local Institution - 0024

    Barcelona, Catalonia, 08008, Spain

  • Local Institution - 0028

    Candiolo, 10060, Italy

  • Local Institution - 0029

    Rosario, Santa Fe Province, 2000, Argentina

  • Local Institution - 0030

    Ravensburg, 88212, Germany

  • Local Institution - 0031

    Lublin, 20-093, Poland

  • Local Institution - 0032

    Genova, 16149, Italy

  • Local Institution - 0035

    Paris, 75018, France

  • Local Institution - 0036

    Lublin, 20-090, Poland

  • Local Institution - 0037

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Local Institution - 0038

    Córdoba, X5004FHP, Argentina

  • Local Institution - 0039

    Viedma, Río Negro Province, 8500, Argentina

  • Local Institution - 0041

    Santiago, Santiago Metropolitan, 7500713, Chile

  • Local Institution - 0042

    Málaga, 29011, Spain

  • Local Institution - 0043

    Valencia, 46026, Spain

  • Local Institution - 0045

    Berlin, 13585, Germany

  • Local Institution - 0048

    Barcelona, 08035, Spain

  • Local Institution - 0050

    Paderborn, 33098, Germany

  • Local Institution - 0051

    A Coruña, 15006, Spain

  • Local Institution - 0052

    Craiova, 200347, Romania

  • Local Institution - 0053

    Harderwijk, Gelderland, 3844, Netherlands

  • Local Institution - 0055

    Camperdown, New South Wales, 2050, Australia

  • Local Institution - 0057

    Adelaide, South Australia, 5087, Australia

  • Local Institution - 0058

    Homburg, 66421, Germany

  • Local Institution - 0059

    Milan, 20141, Italy

  • Local Institution - 0060

    Córdoba, 5006, Argentina

  • Local Institution - 0061

    Las Palmas, 35016, Spain

  • Local Institution - 0062

    Großhansdorf, 22927, Germany

  • Local Institution - 0063

    Natal, Rio Grande do Norte, 59062 000, Brazil

  • Local Institution - 0065

    Essen, North Rhine-Westphalia, 45136, Germany

  • Local Institution - 0067

    Leicester, LE15WW, United Kingdom

  • Local Institution - 0069

    Timișoara, Timiș County, 300166, Romania

  • Local Institution - 0070

    Mexico City, Mexico City, 14050, Mexico

  • Local Institution - 0071

    Marburg, 35043, Germany

  • Local Institution - 0072

    Rio de Janeiro, 20220-410, Brazil

  • Local Institution - 0073

    La Rioja, F5300COE, Argentina

  • Local Institution - 0074

    Madrid, 28041, Spain

  • Local Institution - 0075

    Seville, Andalusia, 41013, Spain

  • Local Institution - 0079

    Santiago, Santiago Metropolitan, 0, Chile

  • Local Institution - 0080

    Olsztyn, 10-357, Poland

  • Local Institution - 0081

    Orange, California, 92868, United States

  • Local Institution - 0082

    Scarborough, Maine, 04074, United States

  • Local Institution - 0083

    Greenville, South Carolina, 29607, United States

  • Local Institution - 0084

    Lancaster, Pennsylvania, 17604, United States

  • Local Institution - 0085

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0086

    Gosford, New South Wales, 2250, Australia

  • Local Institution - 0088

    Warsaw, 02-781, Poland

  • Local Institution - 0089

    Athens, Georgia, 30607, United States

  • Local Institution - 0090

    Graz, 8036, Austria

  • Local Institution - 0091

    Harlingen, Texas, 78550, United States

  • Local Institution - 0092

    Spokane, Washington, 99208, United States

  • Local Institution - 0095

    Manchester, Lancashire, M20 4BX, United Kingdom

  • Local Institution - 0097

    The Bronx, New York, 10461, United States

  • Local Institution - 0099

    Cluj-Napoca, Cluj, 400015, Romania

  • Local Institution - 0101

    London, Greater London, NW1 2PG, United Kingdom

  • Local Institution - 0102

    Paris, 75014, France

  • Local Institution - 0103

    Berlin, 12351, Germany

  • Local Institution - 0104

    Sankt Gallen, 9007, Switzerland

  • Local Institution - 0106

    Rome, RA, 00144, Italy

  • Local Institution - 0107

    Barretos, São Paulo, 14784-400, Brazil

  • Local Institution - 0108

    Löwenstein, 74245, Germany

  • Local Institution - 0109

    Frankston, Victoria, 3199, Australia

  • Local Institution - 0110

    Paris, Île-de-France Region, 75005, France

  • Local Institution - 0111

    Santo André, São Paulo, 09060-870, Brazil

  • Local Institution - 0112

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Local Institution - 0115

    Monterrey, Nuevo León, 64710, Mexico

  • Local Institution - 0116

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Local Institution - 0117

    Durham, North Carolina, 27710, United States

  • Local Institution - 0119

    Murdoch, Western Australia, 6150, Australia

  • Local Institution - 0120

    São Paulo, 08270-120, Brazil

  • Local Institution - 0121

    Wichita, Kansas, 67214, United States

  • Local Institution - 0123

    Madrid, 28046, Spain

  • Local Institution - 0124

    Johnson City, New York, 13790, United States

  • Local Institution - 0125

    Roeselare, 8800, Belgium

  • Local Institution - 0126

    Vienna, 1090, Austria

  • Local Institution - 0127

    Ghent, 9000, Belgium

  • Local Institution - 0128

    New York, New York, 10016, United States

  • Local Institution - 0129

    Omaha, Nebraska, 68130, United States

  • Local Institution - 0130

    Ballarat, Victoria, 3350, Australia

  • Local Institution - 0131

    Ghent, 9000, Belgium

  • Local Institution - 0132

    Tamworth, New South Wales, 2340, Australia

  • Local Institution - 0133

    Elm Park, Dublin, 4, Ireland

  • Local Institution - 0135

    Middlesbrough, Cleveland, TS4 3BW, United Kingdom

  • Local Institution - 0137

    Badalona, Barcelona, 08916, Spain

  • Local Institution - 0138

    Bendigo, Victoria, 3550, Australia

  • Local Institution - 0139

    New Haven, Connecticut, 06520, United States

  • Local Institution - 0141

    Box Hill, Victoria, 3128, Australia

  • Local Institution - 0144

    Le Mans, 72037, France

  • Local Institution - 0145

    Gdynia, 81-519, Poland

  • Local Institution - 0147

    Pittsburgh, Pennsylvania, 15212, United States

  • Local Institution - 0148

    Providence, Rhode Island, 02903, United States

  • Local Institution - 0149

    Dallas, Texas, 75390-9179, United States

  • Local Institution - 0152

    Howell Township, New Jersey, 07731, United States

  • Local Institution - 0153

    Jacksonville, Florida, 32204, United States

  • Local Institution - 0154

    Barcelona, 08025, Spain

  • Local Institution - 0155

    Cleveland, Ohio, 44109, United States

  • Local Institution - 0156

    Cincinnati, Ohio, 45219, United States

  • Local Institution - 0157

    Morgantown, West Virginia, 26506, United States

  • Local Institution - 0158

    Arnhem, 6815, Netherlands

  • Local Institution - 0159

    Lexington, Kentucky, 40503, United States

  • Local Institution - 0160

    Duarte, California, 91010, United States

  • Local Institution - 0161

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Local Institution - 0162

    Mineola, New York, 11501, United States

  • Local Institution - 0163

    São Paulo, 04014-002, Brazil

  • Local Institution - 0164

    Pesaro, 61122, Italy

  • Local Institution - 0165

    New York, New York, 10021, United States

More trials for these conditions

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