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)
| NCT ID | NCT07680764 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Locally Advanced Non-Small Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2026-08-15 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07680764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Non-Small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07680764 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07680764 currently recruiting?
Yes, NCT07680764 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07680764 trial being conducted?
This trial is being conducted at Athens, United States, Lexington, United States, Lexington, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT07680764 clinical trial?
NCT07680764 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 160 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.