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Study of Imzokitug and Pumitamig for Advanced Non-Small Cell Lung Cancer

This study is testing a new combination of treatments for people with locally advanced or metastatic (spread to other parts of the body) non-small cell lung cancer (NSCLC). Researchers want to see how safe and effective Imzokitug is when added to Pumitamig and standard platinum-doublet chemotherapy (PDCT). They will compare this combination to Pumitamig and PDCT alone. You might be able to join if you are 18 or older, have stage IV NSCLC, and haven't had prior systemic anti-cancer therapy for advanced disease. The main goal is to see how many participants respond to the treatment, measured over approximately four years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 160 participants. It will compare two different treatment combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 4 years to assess treatment response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07680764

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
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~160 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:PumitamigImzokitugPemetrexedCisplatinCarboplatinPaclitaxel

At a glance

Recruiting sites
2 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Measured over Up to approximately 4 years

Conditions

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

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Lung Non-Small Cell CarcinomaLung Non-Small Cell Squamous Carcinoma

NCT07680764

Where you'd take part

This study runs at 71 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nebraska Cancer Specialists

    Grand Island, Nebraskastudy coordinator listed

    Recruiting

  • Oncology Hematology West PC

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • Local Institution - 0001

    São Paulo, Brazilno site contact published

    Not yet recruiting

  • Local Institution - 0003

    Natal/RN, Rio Grande do Norte, Brazilno site contact published

    Not yet recruiting

  • Local Institution - 0005

    Barretos, São Paulo, Brazilno site contact published

    Not yet recruiting

  • Local Institution - 0006

    Porto Alegre, Rio Grande do Sul, Brazilno site contact published

    Not yet recruiting

  • Local Institution - 0008

    Cluj-Napoca, Romaniano site contact published

    Not yet recruiting

  • Local Institution - 0010

    Majadahonda, Spainno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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