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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)
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

RecruitingPhase 2

Sponsor: Bristol-Myers Squibb

Conditions: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions: Pumitamig, Imzokitug

Countries: United States, Argentina, Australia, Brazil, Chile, China, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (71)
  • Athens, Georgia, United States
  • Lexington, Kentucky, United States
  • Lexington, Kentucky, United States
  • Baltimore, Maryland, United States
  • Hattiesburg, Mississippi, United States
  • Grand Island, Nebraska, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Madison, Wisconsin, United States
  • Viedma, Río Negro Province, Argentina
  • Rosario, Santa Fe Province, Argentina
  • Buenos Aires, Argentina
  • Gosford, New South Wales, Australia
  • Westmead, New South Wales, Australia
  • Greenslopes, Queensland, Australia
  • Heidelberg, Victoria, Australia
  • Perth, Western Australia, Australia
  • Natal/RN, Rio Grande do Norte, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, Brazil
  • Santiago, Santiago Metropolitan, Chile
  • Santiago, Santiago Metropolitan, Chile
  • Viña del Mar, Valparaiso, Chile
  • Beijing, Beijing Municipality, China
  • Fuzhou, Fujian, China
  • Wuhan, Hubei, China
  • Nanjing, Jiangsu, China
  • + 41 more on CT.gov