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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iza-bren, Carboplatin, Cisplatin, Pemetrexed.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, Canada, Chile +20
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
Interventions
- Drug Iza-bren
Specified dose on specified days - Drug Carboplatin
Specified dose on specified days - Drug Cisplatin
Specified dose on specified days - Drug Pemetrexed
Specified dose on specified days
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Objective Response (OR) Assessed by RECIST v1.1 per BICR [Time frame: Up to 3 years]
- PFS Assessed by RECIST v1.1 per BICR [Time frame: Up to 3 years]
- Overall Survival (OS) [Time frame: Up to 5 years]
- PFS Assessed by RECIST v1.1 per investigator assessment [Time frame: Up to 3 years]
- OR Assessed by RECIST v1.1 per BICR [Time frame: Up to 3 years]
- Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR [Time frame: Up to 3 years]
- Duration of Response (DOR) Assessed by RECIST v1.1 per BICR [Time frame: Up to 3 years]
- Time To Response (TTR) Assessed by RECIST v1.1 per BICR [Time frame: Up to 3 years]
Eligibility 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 28 centers
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building — Irvine
- University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange
- Shaw Cancer Center — Edwards
- Local Institution - 0085 — Gainesville
- Local Institution - 0142 — Pembroke Pines
- Piedmont Healthcare — Atlanta
- John B Amos Cancer Center — Columbus
- Rush University Medical Center — Chicago
- … and 20 more centers
China · 20 centers
- Local Institution - 0244 — Beijing
- Local Institution - 0259 — Chongqing
- Fujian Cancer Hospital — Fuzhou
- Jiangmen Center Hospital — Jiangmen
- Local Institution - 0271 — Anyang
- Local Institution - 0261 — Luoyang
- Local Institution - 0267 — Jingzhou
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan
- … and 12 more centers
Japan · 15 centers
Center list to be confirmed — check the primary protocol.
Germany · 14 centers
- Local Institution - 0207 — Esslingen am Neckar
- Local Institution - 0238 — Esslingen am Neckar
- … and 12 more centers
France · 11 centers
- Local Institution - 0014 — Strasbourg
- Local Institution - 0017 — Toulouse
- Local Institution - 0010 — Lille
- Local Institution - 0018 — La Tronche
- Local Institution - 0170 — Saint-Herblain
- Local Institution - 0162 — Bron
- Local Institution - 0019 — Villejuif
- Local Institution - 0012 — Marseille
- … and 3 more centers
Spain · 10 centers
Center list to be confirmed — check the primary protocol.
India · 9 centers
Center list to be confirmed — check the primary protocol.
Italy · 8 centers
Center list to be confirmed — check the primary protocol.
Romania · 8 centers
Center list to be confirmed — check the primary protocol.
South Korea · 8 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 6 centers
Center list to be confirmed — check the primary protocol.
Belgium · 5 centers
- Local Institution - 0280 — Wilrijk
- Local Institution - 0161 — Auderghem
- Local Institution - 0022 — Yvoir
- Local Institution - 0023 — Ghent
- Local Institution - 0024 — Sint-Niklaas
Canada · 4 centers
- Arthur J. E. Child Comprehensive Cancer Centre — Calgary
- Princess Margaret Cancer Centre — Toronto
- Local Institution - 0184 — Chicoutimi
- Local Institution - 0185 — Montreal
Colombia · 4 centers
- Local Institution - 0229 — Valledupar
- Local Institution - 0228 — Bogotá
- Local Institution - 0227 — Montería
- Local Institution - 0226 — Cali
Greece · 4 centers
Center list to be confirmed — check the primary protocol.
Mexico · 4 centers
Center list to be confirmed — check the primary protocol.
Thailand · 4 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Argentina · 3 centers
- Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires
- Local Institution - 0004 — ABB
- Hospital Privado Universitario de Córdoba — Córdoba
Chile · 3 centers
- Local Institution - 0006 — Santiago
- Local Institution - 0005 — Santiago
- Local Institution - 0007 — Santiago
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Norway · 3 centers
Center list to be confirmed — check the primary protocol.
Poland · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 3 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07100080 · CA244-0010 · EU CTR · WHO · CA2440010