Locally Advanced Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT07680764

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Pumitamig, Imzokitug and Pemetrexed in people with Locally Advanced Non-Small Cell Lung Cancer (NSCLC) and Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 74 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)
What is being tested?: Pumitamig, Imzokitug and Pemetrexed
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 74 sitesin 12 countries
Study dates: 10 Sep 2026to 15 Sep 2030
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition.
Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site.
Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Who cannot join

Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated.
Participants must not have prior treatment with immuno-oncology therapies.
Participants must not have untreated central nervous system (CNS) metastases.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

74 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Country

City, postcode or hospital

Sites recruiting now only

74 sites in 12 countries

United States12 sites, 12 recruiting

University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Frederick Flynt Jr, Site 0170, 402-334-4773
Recruiting
Local Institution - 0123
Baltimore, Maryland, 21224
Site 0123
Not yet recruiting
Local Institution - 0176
Columbus, Ohio, 43210
Site 0176
Not yet recruiting
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
Joel Michalski, Site 0172, 402-955-2691
Recruiting
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
John Hrom, Site 0180, 601-261-1700
Recruiting
Local Institution - 0095
Houston, Texas, 77030
Site 0095
Not yet recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
Firas Badin, Site 0034, 859-276-0414
Recruiting
Baptist Health Hamburg
Lexington, Kentucky, 40509
Firas Badin, Site 0171, 859-260-6100
Recruiting
Local Institution - 0135
Madison, Wisconsin, 53792
Site 0135
Not yet recruiting
Local Institution - 0080
New York, New York, 10021
Site 0080
Not yet recruiting
Oncology Hematology West PC
Omaha, Nebraska, 68130
Joel Michalski, Site 0102, 402-955-2691
Recruiting
Local Institution - 0183
Washington D.C., District of Columbia, 20016
Site 0183
Not yet recruiting

Other trials in United States

France9 sites, 9 recruiting

Local Institution - 0047
Grenoble, 38043 Cedex 09
Site 0047
Not yet recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
Laurent Greillier, Site 0110, 33491324400
Recruiting
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, 34090
Benoit Roch, Site 0117, +33467330759
Recruiting
Local Institution - 0087
Montpellier, Languedoc-Roussillon, 34070
Site 0087
Not yet recruiting
Local Institution - 0131
Nice, Alpes-Maritimes, 6100
Site 0131
Not yet recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
Marie Wislez, Site 0109, 33158413091
Recruiting
Local Institution - 0019
Paris, Île-de-France Region, 75005
Site 0019
Not yet recruiting
Local Institution - 0085
Saint-Herblain, 44800
Site 0085
Not yet recruiting
Local Institution - 0119
Villejuif, Val-de-Marne, 94800
Site 0119
Not yet recruiting

Other trials in France

China8 sites, 8 recruiting

Local Institution - 0038
Beijing, Beijing Municipality, 100142
Site 0038
Not yet recruiting
Local Institution - 0144
Chengdu, Sichuan, 610213
Site 0144
Not yet recruiting
Local Institution - 0138
Fuzhou, Fujian, 350014
Site 0138
Not yet recruiting
Local Institution - 0137
Hangzhou, Zhejiang, 310016
Site 0137
Not yet recruiting
Local Institution - 0147
Nanjing, Jiangsu, 210029
Site 0147
Not yet recruiting
Local Institution - 0140
Shanghai, Shanghai Municipality, 200030
Site 0140
Not yet recruiting
Local Institution - 0169
Shanghai, Shanghai Municipality, 200032
Site 0169
Not yet recruiting
Local Institution - 0050
Wuhan, Hubei, 430030
Site 0050
Not yet recruiting

Other trials in China

Spain8 sites, 7 recruiting

Local Institution - 0132
Badalona, Barcelona, 8916
Site 0132
Not yet recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Enriqueta Felip Font, Site 0027, 34932746077
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Margarita Majem Tarruella, Site 0068, 34935565651
Recruiting
Local Institution - 0163
Barcelona, 8036
Site 0163
Not yet recruiting
Local Institution - 0041
Madrid, 28041
Withdrawn
Local Institution - 0010
Majadahonda, 28222
Site 0010
Not yet recruiting
Hospital Carlos Haya De Malaga
Málaga, 29010
Manuel Cobo-Dols, Site 0020, 00349422033350000
Recruiting
Local Institution - 0162
Seville, Seville, 41013
Site 0162
Not yet recruiting

Other trials in Spain

Romania7 sites, 7 recruiting

Institutul Oncologic "Prof. Dr. Alexandru Trestioreanu" Bucuresti (IOB)
Bucharest, 022328
Aurelia Alexandru, Site 0076, 40723289606
Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0008, 40745646368
Recruiting
Centrul de Oncologie Sf. Nectarie SRL
Craiova, 200347
Michael Schenker, Site 0075, 40727774974
Recruiting
Amethyst Radiotherapy Center-Oncologie Medicala
Florești, Cluj, 407280
Andrei Ungureanu, Site 0114, 40742206212
Recruiting
Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)
Iași, 700106
Constantin Volovat, Site 0115, 40746110096
Recruiting
Institutul Regional de Oncologie Iasi
Iași, 700483
Dana Clement, Site 0116, 40744692062
Recruiting
Oncohelp
Timisoara, Timis, 300239
Daniela Sirbu, Site 0113, 40744571617
Recruiting

Other trials in Romania

Germany6 sites, 6 recruiting

Klinikum Köln-Merheim
Cologne, 51109
Eva-Lotte Buchmeier, Site 0065, +49221890713962
Recruiting
Christliches Klinikum Halle (Saale) GmbH
Halle, 06120
Miriam Moeller, Site 0042, 00493455591440
Recruiting
Universitatsklinikum Frankfurt
Hessen, 60590
Friederike Althoff, Site 0125
Recruiting
Local Institution - 0152
Homburg, Saarland, 66424
Site 0152
Not yet recruiting
Local Institution - 0156
Marburg, Hesse, 35043
Site 0156
Not yet recruiting
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, 70376
Martin Kimmich, Site 0126, 4971181017719
Recruiting

Other trials in Germany

Italy6 sites, 6 recruiting

Local Institution - 0043
Bari, 70124
Site 0043
Not yet recruiting
Local Institution - 0148
Bergamo, BG, 24127
Site 0148
Not yet recruiting
Local Institution - 0159
Milan, 20142
Site 0159
Not yet recruiting
Humanitas Istituto Clinico Catanese
Misterbianco, Catania, 95045
Alessandro Russo, Site 0128, 393280569761
Recruiting
Local Institution - 0014
Ravenna, 48121
Site 0014
Not yet recruiting
Local Institution - 0011
Rozzano (MI), 20089
Site 0011
Not yet recruiting

Other trials in Italy

Australia5 sites, 5 recruiting

Gosford Hospital
Gosford, New South Wales, 2250
Matthew Chan, Site 0074
Recruiting
Local Institution - 0167
Greenslopes, Queensland, 4120
Site 0167
Not yet recruiting
Local Institution - 0100
Heidelberg, Victoria, 3084
Site 0100
Not yet recruiting
St. John of God Murdoch Hospital
Perth, Western Australia, 6150
Kynan Feeney, Site 0048, +61894389599
Recruiting
Local Institution - 0134
Westmead, New South Wales, 2145
Site 0134
Not yet recruiting

Other trials in Australia

Brazil4 sites, 4 recruiting

Local Institution - 0005
Barretos, São Paulo, 14784
Site 0005
Not yet recruiting
Local Institution - 0003
Natal/RN, Rio Grande do Norte, 59062-000
Site 0003
Not yet recruiting
Local Institution - 0006
Porto Alegre, Rio Grande do Sul, 91610-000
Site 0006
Not yet recruiting
Local Institution - 0001
São Paulo, 01246-000
Site 0001
Not yet recruiting

Other trials in Brazil

Argentina3 sites, 3 recruiting

Instituto Medico Especializado Alexander Fleming
Buenos Aires, C1426ANZ
Claudio Martin, Site 0094, 5491166936669
Recruiting
Sanatorio Parque Rosario
Rosario, Santa Fe Province, 2000
Gaston Martinengo, Site 0082, 5493416955611
Recruiting
Clinica Viedma S.A.
Viedma, R8500ACE
Ruben Kowalyszyn, Site 0092, 5492920601693
Recruiting

Other trials in Argentina

Chile3 sites, 3 recruiting

Orlandi Oncologia
Santiago, Santiago Metropolitan, 7500713
Francisco Orlandi, Site 0081, 56992214787
Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0149, +56998744662
Recruiting
Oncocentro Apys
Viña del Mar, Valparaiso, 2520598
Alejandro Acevedo Gaete, Site 0084, +56992369820
Recruiting

Other trials in Chile

United Kingdom3 sites, 3 recruiting

Local Institution - 0182
Birmingham, BIR, B9 5SS
Site 0182
Not yet recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
Ali Suwaidan, Site 0037, 01483571122
Recruiting
Local Institution - 0035
London, Greater London, SE19RT
Site 0035
Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Conditions: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)
Being tested: Pumitamig, Imzokitug, Pemetrexed, Cisplatin, Carboplatin
Keywords: Squamous Non-Small Cell Lung Cancer (NSCLC), Non-squamous Non-Small Cell Lung Cancer (NSCLC), Immunotherapy, Bispecific antibody, Imzokitug, Anti-CCR8 monoclonal antibody
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PumitamigDrug
Also called BMS-986545, BNT327, PM8002
Specified dose on specified days
ImzokitugDrug
Also called Anti-CCR8, BMS-986340
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days

Study groups in NCT07680764
Study group	Role	What they receive
Arm A: Pumitamig + Imzokitug + Histology-based PDCT	Experimental	Not described Receives: Drug: Pumitamig; Drug: Imzokitug; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel
Arm B: Pumitamig + Imzokitug + Histology-based PDCT	Experimental	Not described Receives: Drug: Pumitamig; Drug: Imzokitug; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel
Arm C: Pumitamig + Imzokitug + Histology-based PDCT	Experimental	Not described Receives: Drug: Pumitamig; Drug: Imzokitug; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel
Arm D: Pumitamig + Histology-based PDCT	Experimental	Not described Receives: Drug: Pumitamig; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Measured: Up to approximately 4 years

Secondary outcomes (10)

Number of participants with adverse events (AEs)
Measured: Up to 90 days after discontinuation of study treatment
Number of participants with serious adverse events (SAEs)
Measured: Up to 90 days after discontinuation of study treatment
Number of participants with treatment-related AEs
Measured: Up to 90 days after discontinuation of study treatment
Number of participants with treatment-related SAEs
Measured: Up to 90 days after discontinuation of study treatment
Number of participants with AEs leading to discontinuation
Measured: Up to 90 days after discontinuation of study treatment
Number of deaths
Measured: Up to 90 days after discontinuation of study treatment
Progression free survival (PFS) by investigator (per RECIST v1.1)
Measured: Up to approximately 4 years
Overall survival (OS)
Measured: Up to approximately 4 years
Duration of response (DOR) by investigator (per RECIST v1.1)
Measured: Up to approximately 4 years
Time to recurrence (TTR) by investigator (per RECIST v1.1)
Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202615 Sep 2030

First posted2 Jul 2026
Study start10 Sep 2026
Primary completion15 Sep 2028 (estimated)
Study completion15 Sep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07680764
Sponsor's protocol ID: CA052-1000
Other IDs: 2026-525170-19, U1111-1333-5867
Status last verified: Oct 2026
First submitted: 26 Jun 2026
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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