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)

Not Applicable

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Iza-bren; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

• Registration Number: NCT07100080
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Status Verified: 2025-08
• Study First Posted: 2025-08-03
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-19
• Study Start: 2025-10-15
• Primary Completion: 2028-09-15
• Study Completion: 2031-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 596

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Iza-bren	-
Arm B	Iza-bren	-
Arm C	Carboplatin	-
Arm C	Cisplatin	-
Arm C	Pemetrexed	-
Arm D	Iza-bren	-
Arm E	Carboplatin	-
Arm E	Cisplatin	-
Arm E	Pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Recommended Phase 3 Dose (RP3D) of BMS-986507	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)	Up to 3 years	Phase 3

Secondary Outcome Measures

Name	Time	Method
Objective Response (OR) Assessed by RECIST v1.1 per BICR	Up to 3 years	Phase 2
PFS Assessed by RECIST v1.1 per BICR	Up to 3 years	Phase 2
Overall Survival (OS)	Up to 5 years	Phase 3
PFS Assessed by RECIST v1.1 per investigator assessment	Up to 3 years	Phase 3
OR Assessed by RECIST v1.1 per BICR	Up to 3 years	Phase 3
Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR	Up to 3 years	Phase 3
Duration of Response (DOR) Assessed by RECIST v1.1 per BICR	Up to 3 years	Phase 3
Time To Response (TTR) Assessed by RECIST v1.1 per BICR	Up to 3 years	Phase 3

Trial Locations

Locations (153)

Local Institution - 0154; 🇺🇸 Orange, California, United States

Local Institution - 0139; 🇺🇸 Edwards, Colorado, United States

Local Institution - 0085; 🇺🇸 Gainesville, Florida, United States

Local Institution - 0270; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0143; 🇺🇸 Columbus, Georgia, United States

Local Institution - 0153; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0067; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0091; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0269; 🇺🇸 Mineola, New York, United States

Local Institution - 0090; 🇺🇸 New York, New York, United States

Scroll for more (143 remaining)