Not yet recruiting NCT07680790

Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

Phase III Interventional Non-Small Cell Lung Cancer

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, Osimertinib, Pemetrexed, Carboplatin.
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, Australia, Brazil, Canada +10
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

A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

Overview

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

Interventions

Drug Iza-bren
Specified dose on specified days
Drug Osimertinib
Specified dose on days
Drug Pemetrexed
Specified dose on specified days
Drug Carboplatin
Specified dose on specified days
Drug Cisplatin
Specified dose on specified days

Primary outcome measures

Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [Time frame: Up to approximately 3 years]

Secondary outcome measures (9)

Overall Survival (OS) [Time frame: Up to approximately 5 years]
PFS assessed by the investigator as per RECIST v1.1 [Time frame: Up to approximately 3 years]
Second Progression-Free Survival (PFS2) as assessed by the Investigator [Time frame: Up to approximately 5 years]
Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1 [Time frame: Up to approximately 3 years]
Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1 [Time frame: Up to approximately 3 years]
Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1 [Time frame: Up to approximately 3 years]
Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1 [Time frame: Up to approximately 3 years]
Duration of Response (DOR) assessed by the BICR as per RECIST v1.1 [Time frame: Up to approximately 3 years]
Duration of Response (DOR) assessed by the investigator as per RECIST v1.1 [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)
Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator
Participants must have ECOG Performance Status 0-1

Exclusion criteria

Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression
Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis
Participants must not have clinically significant cardiac disease
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

China · 37 centers

Local Institution - 0517 — Beijing
Local Institution - 0458 — Beijing
Local Institution - 0470 — Chongqing
Local Institution - 0493 — Fuzhou
Local Institution - 0457 — Fuzhou
Local Institution - 0326 — Dongguan Shi
Local Institution - 0331 — Guangzhou
Local Institution - 0478 — Zhongshan
… and 29 more centers

United States · 34 centers

Local Institution - 0212 — Beverly Hills
Local Institution - 0504 — Fullerton
Local Institution - 0357 — La Jolla
Local Institution - 0520 — Pueblo
Local Institution - 0527 — Fort Myers
Local Institution - 0366 — Orlando
Local Institution - 0519 — Palm Bay
Local Institution - 0210 — Honolulu
… and 26 more centers

Germany · 17 centers