A Study To Assess the Safety, Tolerability, and Efficacy... | NCT07680764

Studies
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

Sponsor

Bristol-Myers Squibb

Status

Not yet recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

160Estimated

Phase

Phase 2

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
Italy
Romania
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2026-525170-19	Other Identifier	EU CT Number
U1111-1333-5867	Other Identifier	WHO

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2026Estimated

Primary Completion Date

Sep 15, 2028Estimated

Completion Date

Sep 15, 2030Estimated

First Submitted Date

Jun 26, 2026

First Submission Date that Met QC Criteria

Jun 26, 2026

First Posted Date

Jul 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm A	Experimental	Drug: Pumitamig Drug: Imzokitug
Arm B	Experimental	Drug: Pumitamig Drug: Imzokitug
Arm C	Experimental	Drug: Pumitamig Drug: Imzokitug
Arm D	Experimental	Drug: Pumitamig

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pumitamig	Drug	Specified dose on specified days	Arm A Arm B Arm C Arm D

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (AEs)		Up to 90 days after discontinuation of study treatment
Number of participants with serious adverse events (SAEs)		Up to 90 days after discontinuation of study treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com	Contact	855-907-3286		Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.	Contact

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0170		Athens	Georgia	30607	United States

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See Plan Description

Access Criteria

See Plan Description

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases