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 now · Phase 2
Conditions studied: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)
In brief
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)
Key facts
- Study ID
- NCT07680764
- Run by
- Bristol-Myers Squibb
- People needed
- 160
- Starts
- 2026-08-15
- Expected to finish
- 2030-09-15
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Nebraska Cancer Specialists — Grand Island, Nebraska, United States (enrolling)
- Oncology Hematology West PC — Omaha, Nebraska, United States (enrolling)
- Local Institution - 0171 — Lexington, Kentucky, United States
- Local Institution - 0180 — Hattiesburg, Mississippi, United States
- Local Institution - 0092 — Viedma, Río Negro Province, Argentina
- Local Institution - 0094 — Buenos Aires, Argentina
- Local Institution - 0105 — Nashville, Tennessee, United States
- Local Institution - 0134 — Westmead, New South Wales, Australia
- Local Institution - 0095 — Houston, Texas, United States
- Local Institution - 0135 — Madison, Wisconsin, United States
- Local Institution - 0081 — Santiago, Santiago Metropolitan, Chile
- Local Institution - 0082 — Rosario, Santa Fe Province, Argentina
- Local Institution - 0080 — New York, New York, United States
- Local Institution - 0074 — Gosford, New South Wales, Australia
- Local Institution - 0123 — Baltimore, Maryland, United States
- Local Institution - 0167 — Greenslopes, Queensland, Australia
- Local Institution - 0100 — Heidelberg, Victoria, Australia
- Local Institution - 0048 — Perth, Western Australia, Australia
- Local Institution - 0003 — Natal/RN, Rio Grande do Norte, Brazil
- Local Institution - 0006 — Porto Alegre, Rio Grande do Sul, Brazil
- Local Institution - 0005 — Barretos, São Paulo, Brazil
- Local Institution - 0001 — São Paulo, Brazil
- Local Institution - 0034 — Lexington, Kentucky, United States
- Local Institution - 0149 — Santiago, Santiago Metropolitan, Chile
- Local Institution - 0170 — Athens, Georgia, United States
Full record on ClinicalTrials.gov
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