Recruiting
Phase 2
Phase 3

Izalontamab vs. Platinum-Pemetrexed

Sponsor:

Bristol-Myers Squibb

Code:

NCT07100080

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Iza-bren

Carboplatin

Cisplatin

Pemetrexed

Study Details

Brief summary:

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07100080

Start date

Nov 5, 2025

Status verified date

Aug, 2026

Completion date

Nov 15, 2030

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Non-squamous NSCLC, not amenable to treatment in curative intent.
  • Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
  • Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
  • Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).

Exclusion criteria:

  • Inadequate organ function and/or bone marrow reserve.
  • Leptomeningeal metastases or spinal cord compression.
  • Poorly controlled systemic medical conditions.
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

experimental: Arm B

active comparator: Arm C

experimental: Arm D

active comparator: Arm E

Interventions

Iza-bren

Specified dose on specified days

Carboplatin

Specified dose on specified days

Cisplatin

Specified dose on specified days

Pemetrexed

Specified dose on specified days

Primary outcome measure

  • Recommended Phase 3 Dose (RP3D) of BMS-986507 [ Time Frame: Approximately 3 months after the first dose ]
  • Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building

Recruiting

Irvine, California, United States, 92612

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868-3201

Shaw Cancer Center

Recruiting

Edwards, Colorado, United States, 81632

Contacts

Erin Schwab, Site 0139

970-569-7608

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Andrew Pippas, Site 0270

706-660-6449

John B Amos Cancer Center

Recruiting

Columbus, Georgia, United States, 31904

Contacts

Andrew Pippas, Site 0143

706-660-6449

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Helen Ross, Site 0153

312-942-5904

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Julia Rotow, Site 0067

617-632-6049

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Ece Cali Daylan, Site 0091

314-273-8008

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Katharine Thomas, Site 0276

775-985-4000

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Rajwanth Veluswamy, Site 0269

212-731-5662

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Rajwanth Veluswamy, Site 0090

212-731-5662

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Ashish Saxena, Site 0158

631-745-0359

Rochester General Hospital Infectious Disease

Recruiting

Rochester, New York, United States, 14621

Contacts

MEHUL PATEL, Site 0186

585-922-4020

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Matthew Mirsky, Site 0087

301-980-8969

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Regan Memmott, Site 0284

614-688-7567

Providence Cancer Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97213

Contacts

Rachel Sanborn, Site 0038

503-215-5696

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Rachel Sanborn, Site 0275

503-215-5696

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Melina Marmarelis, Site 0205

267-438-8154

West Penn Allegheny Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Ariel Lopez Chavez, Site 0088

503-494-8426

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Wade Iams, Site 0093

615-322-4967

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Ryan Gentzler, Site 0145

434-924-4251

Virginia Commonwealth University (Vcu)

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Renato Martins, Site 0138

804-828-7999

Arthur J. E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Doreen Ezeife, Site 0190

0000000000

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Natasha Leighl, Site 0183

4169464645

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Epidermal Growth Factor Receptor
  • Tyrosine Kinase Inhibitors
  • Osimertinib
  • Standard of Care
  • Lung Neoplasms
  • Antineoplastic Agents
  • Izalontamab brengitecan
  • Iza-bren
  • BL-B01D1
  • Carboplatin
  • Cisplatin
  • Pemetrexed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-25.