Imzokitug with Pumitamig and PDCT as first-line treatment for locally advanced or metastatic NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study compares Imzokitug in combination with Pumitamig and platinum-doublet chemotherapy (PDCT) to Pumitamig plus PDCT alone as first-line treatment for NSCLC. It includes patients with either squamous or non-squamous NSCLC who have not yet received systemic therapy for advanced disease and meet eligibility criteria. Key assessments include safety, tolerability, and preliminary efficacy using RECIST 1.1. Participants will receive standard chemotherapy with either cisplatin or carboplatin in combination with pemetrexed as appropriate. Tissue samples collected near enrollment support biomarker considerations.

Why it matters

Who can join: the full rules

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's running

• University Cancer & Blood Center, LLC
  Athens, Georgia, United States Recruiting
• Baptist Health Lexington
  Lexington, Kentucky, United States Recruiting
• Baptist Health Hamburg
  Lexington, Kentucky, United States Recruiting
• Hattiesburg Clinic
  Hattiesburg, Mississippi, United States Recruiting
• Nebraska Cancer Specialists
  Grand Island, Nebraska, United States Recruiting
• Oncology Hematology West PC
  Omaha, Nebraska, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.