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Clinical Trials List

Protocol NumberCA244-0010

NCT Number(ClinicalTrials.gov Identfier)NCT07100080

Active

2025-10-01 - 2028-12-31

Recruiting6

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

Trial Applicant

BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/04/10

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-YUAN SHIH 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰無

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

Phase 2 Primary Objective: • To determine the Phase 3 Recommended Dosage (RP3D) of iza-bren for Phase 3 of this trial. Phase 3 Primary Objective: • To compare progression-free survival (PFS) of iza-bren versus PBC at RP3D in participants with advanced EGFR-mediated NSCLC who experienced disease progression following treatment with any third-generation TKI.

Test Drug

Injectable frozen powder

Active Ingredient

BMS-986507

Dosage Form

048

Dosage

120 mg/Vial

Endpoints

• RP3D will be determined based on overall safety, tolerability, efficacy, and pharmacokinetic (PK)/pharmacodynamic data.

• BICR will assess PFS based on RECIST v1.1.

Inclution Criteria

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

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.

The Estimated Number of Participants

Taiwan

37 participants
Global

917 participants