Studieoverzicht

Study name: 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

Histology	NSCLC, only non-squamous
Tumor stage	Stage III - IV
NCT Id	NCT07100080
Host / recruiting site 1	Amsterdam UMC	Enrollment	Planned
Therapy line	Later line (≥2L)
Design	A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
Intervention	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
Key outcome parameters	Recommended Phase 3 Dose (RP3D) of BMS-986507 Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Key inclusion 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).
Key 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.
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