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)

Recruiting · NCT07680764 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Lung cancer

Interventions studied

ImzokitugPumitamig

What this trial is about

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)

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 9 US states.

Local Institution - 0170 - Athens, Georgia, United States
Local Institution - 0034 - Lexington, Kentucky, United States
Local Institution - 0171 - Lexington, Kentucky, United States
Local Institution - 0123 - Baltimore, Maryland, United States
Local Institution - 0180 - Hattiesburg, Mississippi, United States
Nebraska Cancer Specialists - Grand Island, Nebraska, United States
Oncology Hematology West PC - Omaha, Nebraska, United States
Local Institution - 0080 - New York, New York, United States
Local Institution - 0105 - Nashville, Tennessee, United States
Local Institution - 0095 - Houston, Texas, United States
Local Institution - 0135 - Madison, Wisconsin, United States
Local Institution - 0027 - Barcelona, Spain
Local Institution - 0068 - Barcelona, Spain
Local Institution - 0163 - Barcelona, Spain
Local Institution - 0043 - Bari, Italy
Local Institution - 0148 - Bergamo, Italy
Local Institution - 0076 - Bucharest, Romania
Local Institution - 0094 - Buenos Aires, Argentina
Local Institution - 0008 - Cluj-Napoca, Romania
Local Institution - 0065 - Cologne, Germany
Local Institution - 0075 - Craiova, Romania
Local Institution - 0047 - Grenoble, France
Local Institution - 0037 - Guildford, United Kingdom
Local Institution - 0042 - Haile, Germany
Local Institution - 0125 - Hessen, Germany
Local Institution - 0115 - Iași, Romania
Local Institution - 0116 - Iași, Romania
Local Institution - 0041 - Madrid, Spain
Local Institution - 0010 - Majadahonda, Spain
Local Institution - 0159 - Milan, Italy
Local Institution - 0020 - Málaga, Spain
Local Institution - 0109 - Paris, France
Local Institution - 0014 - Ravenna, Italy
Local Institution - 0011 - Rozzano (MI), Italy
Local Institution - 0085 - Saint-Herblain, France
Local Institution - 0001 - São Paulo, Brazil
Local Institution - 0131 - Nice, Alpes-Maritimes, France
Local Institution - 0126 - Stuttgart, Baden-Wurttemberg, Germany
Local Institution - 0132 - Badalona, Barcelona, Spain
Local Institution - 0038 - Beijing, Beijing Municipality, China
Local Institution - 0110 - Marseille, Bouches-du-Rhône, France
Local Institution - 0128 - Misterbianco, Catania, Italy
Local Institution - 0114 - Florești, Cluj, Romania
Local Institution - 0138 - Fuzhou, Fujian, China
Local Institution - 0035 - London, Greater London, United Kingdom
Local Institution - 0156 - Marburg, Hesse, Germany
Local Institution - 0050 - Wuhan, Hubei, China
Local Institution - 0147 - Nanjing, Jiangsu, China
Local Institution - 0087 - Montpellier, Languedoc-Roussillon, France
Local Institution - 0074 - Gosford, New South Wales, Australia
Local Institution - 0134 - Westmead, New South Wales, Australia
Local Institution - 0167 - Greenslopes, Queensland, Australia
Local Institution - 0003 - Natal/RN, Rio Grande do Norte, Brazil
Local Institution - 0006 - Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0092 - Viedma, Río Negro Province, Argentina
Local Institution - 0152 - Homburg, Saarland, Germany
Local Institution - 0082 - Rosario, Santa Fe Province, Argentina
Local Institution - 0081 - Santiago, Santiago Metropolitan, Chile
Local Institution - 0149 - Santiago, Santiago Metropolitan, Chile
Local Institution - 0162 - Seville, Seville, Spain

Showing 60 of 71 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →