Iza-bren
DrugSpecified dose on specified days
Other names: BMS-986507, BL-B01D1, Izalontamab brengitecan
Recruiting
NCT Number: NCT07100080
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Local Institution - 0008, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
carboplatin
DrugSpecified dose on specified days
Cisplatin
DrugSpecified dose on specified days
Pemetrexed
DrugSpecified dose on specified days
Primary outcomes
-
Recommended Phase 3 Dose (RP3D) of BMS-986507
Time frame: Approximately 3 months after the first dose
Phase 2
-
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
Phase 3
Secondary outcomes
-
Objective Response (OR) Assessed by RECIST v1.1 per BICR
Time frame: Up to 3 years
Phase 2
-
PFS Assessed by RECIST v1.1 per BICR
Time frame: Up to 3 years
Phase 2
-
Overall Survival (OS)
Time frame: Up to 5 years
Phase 3
-
PFS Assessed by RECIST v1.1 per investigator assessment
Time frame: Up to 3 years
Phase 3
-
OR Assessed by RECIST v1.1 per BICR
Time frame: Up to 3 years
Phase 3
-
Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR
Time frame: Up to 3 years
Phase 3
-
Duration of Response (DOR) Assessed by RECIST v1.1 per BICR
Time frame: Up to 3 years
Phase 3
-
Time To Response (TTR) Assessed by RECIST v1.1 per BICR
Time frame: Up to 3 years
Phase 3
Study contacts
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
Important dates
- Study start
- 2025
- Primary completion
- 2028
- Study completion
- 2030
- First posted
- Aug 3, 2025
- Registry last updated
- Jun 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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