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

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521908-22-00

Acronym

CA244-0010

Enrollment

193

Registered

2026-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR-mutated Non-small Cell Lung Cancer

Brief summary

Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data, Phase 3: progression-free survival by RECIST v1.1 per Blinded Independent Central Review.

Detailed description

Phase 2: Overall Survival by RECIST v1.1 per Blinded Independent Central Review, Phase 2: Progression-Free Survival rates by RECIST v1.1 per Blinded Independent Central Review, Phase 3: overall survival (OS).

Interventions

DRUGPEGFILGRASTIM

DRUGBL-B01D1

DRUGCARBOPLATIN

DRUGCISPLATIN

DRUGPEMETREXED

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data, Phase 3: progression-free survival by RECIST v1.1 per Blinded Independent Central Review.	—

Secondary

Measure	Time frame
Phase 2: Overall Survival by RECIST v1.1 per Blinded Independent Central Review, Phase 2: Progression-Free Survival rates by RECIST v1.1 per Blinded Independent Central Review, Phase 3: overall survival (OS).	—

Countries

Belgium, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026