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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)

NCT07680764 · Bristol-Myers Squibb
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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)
About this study
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)
Eligibility criteria
Inclusion Criteria * 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. Exclusion Criteria * 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.
Study design
Enrollment target: 160 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-08-31
Estimated completion: 2030-09-15
Last updated: 2026-09-16
Interventions
Drug: PumitamigDrug: ImzokitugDrug: PemetrexedDrug: CisplatinDrug: CarboplatinDrug: PaclitaxelDrug: InfliximabDrug: Vedolizumab
Primary outcomes
  • Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) (Up to approximately 4 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (71)
Local Institution - 0170Not Yet Recruiting
Athens, Georgia, United States
Local Institution - 0034Not Yet Recruiting
Lexington, Kentucky, United States
Local Institution - 0171Not Yet Recruiting
Lexington, Kentucky, United States
Local Institution - 0123Not Yet Recruiting
Baltimore, Maryland, United States
Local Institution - 0180Not Yet Recruiting
Hattiesburg, Mississippi, United States
Nebraska Cancer SpecialistsRecruiting
Grand Island, Nebraska, United States
Oncology Hematology West PCRecruiting
Omaha, Nebraska, United States
Local Institution - 0080Not Yet Recruiting
New York, New York, United States
Local Institution - 0095Not Yet Recruiting
Houston, Texas, United States
Local Institution - 0135Not Yet Recruiting
Madison, Wisconsin, United States
Local Institution - 0082Not Yet Recruiting
Rosario, Santa Fe Province, Argentina
Local Institution - 0094Not Yet Recruiting
Buenos Aires, Argentina
Local Institution - 0092Not Yet Recruiting
Viedma, Argentina
Local Institution - 0074Not Yet Recruiting
Gosford, New South Wales, Australia
Local Institution - 0134Not Yet Recruiting
Westmead, New South Wales, Australia
Local Institution - 0167Not Yet Recruiting
Greenslopes, Queensland, Australia
Local Institution - 0100Not Yet Recruiting
Heidelberg, Victoria, Australia
Local Institution - 0048Not Yet Recruiting
Perth, Western Australia, Australia
Local Institution - 0003Not Yet Recruiting
Natal/RN, Rio Grande do Norte, Brazil
Local Institution - 0006Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0005Not Yet Recruiting
Barretos, São Paulo, Brazil
Local Institution - 0001Not Yet Recruiting
São Paulo, Brazil
Local Institution - 0081Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0149Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0084Not Yet Recruiting
Viña del Mar, Valparaiso, Chile
Local Institution - 0038Not Yet Recruiting
Beijing, Beijing Municipality, China
Local Institution - 0138Not Yet Recruiting
Fuzhou, Fujian, China
Local Institution - 0050Not Yet Recruiting
Wuhan, Hubei, China
Local Institution - 0147Not Yet Recruiting
Nanjing, Jiangsu, China
Local Institution - 0140Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0169Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0144Not Yet Recruiting
Chengdu, Sichuan, China
Local Institution - 0137Not Yet Recruiting
Hangzhou, Zhejiang, China
Local Institution - 0131Not Yet Recruiting
Nice, Alpes-Maritimes, France
Local Institution - 0110Not Yet Recruiting
Marseille, Bouches-du-Rhône, France
Local Institution - 0087Not Yet Recruiting
Montpellier, Languedoc-Roussillon, France
Local Institution - 0119Not Yet Recruiting
Villejuif, Val-de-Marne, France
Local Institution - 0047Not Yet Recruiting
Grenoble, France
Local Institution - 0109Not Yet Recruiting
Paris, France
Local Institution - 0085Not Yet Recruiting
Saint-Herblain, France
Local Institution - 0019Not Yet Recruiting
Paris, Île-de-France Region, France
Local Institution - 0126Not Yet Recruiting
Stuttgart, Baden-Wurttemberg, Germany
Local Institution - 0156Not Yet Recruiting
Marburg, Hesse, Germany
Local Institution - 0152Not Yet Recruiting
Homburg, Saarland, Germany
Local Institution - 0065Not Yet Recruiting
Cologne, Germany
Local Institution - 0042Not Yet Recruiting
Haile, Germany
Local Institution - 0125Not Yet Recruiting
Hessen, Germany
Local Institution - 0128Not Yet Recruiting
Misterbianco, Catania, Italy
Local Institution - 0043Not Yet Recruiting
Bari, Italy
Local Institution - 0148Not Yet Recruiting
Bergamo, Italy
Local Institution - 0159Not Yet Recruiting
Milan, Italy
Local Institution - 0014Not Yet Recruiting
Ravenna, Italy
Local Institution - 0011Not Yet Recruiting
Rozzano (MI), Italy
Local Institution - 0114Not Yet Recruiting
Florești, Cluj, Romania
Local Institution - 0113Not Yet Recruiting
Timișoara, Timiș County, Romania
Local Institution - 0076Not Yet Recruiting
Bucharest, Romania
Local Institution - 0008Not Yet Recruiting
Cluj-Napoca, Romania
Local Institution - 0075Not Yet Recruiting
Craiova, Romania
Local Institution - 0115Not Yet Recruiting
Iași, Romania
Local Institution - 0116Not Yet Recruiting
Iași, Romania
Local Institution - 0132Not Yet Recruiting
Badalona, Barcelona, Spain
Local Institution - 0162Not Yet Recruiting
Seville, Seville, Spain
Local Institution - 0027Not Yet Recruiting
Barcelona, Spain
Local Institution - 0068Not Yet Recruiting
Barcelona, Spain
Local Institution - 0163Not Yet Recruiting
Barcelona, Spain
Local Institution - 0041Withdrawn
Madrid, Spain
Local Institution - 0010Not Yet Recruiting
Majadahonda, Spain
Local Institution - 0020Not Yet Recruiting
Málaga, Spain
Local Institution - 0035Not Yet Recruiting
London, Greater London, United Kingdom
Local Institution - 0182Not Yet Recruiting
Birmingham, West Midlands, United Kingdom
Local Institution - 0037Not Yet Recruiting
Guildford, United Kingdom