Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, EGFR, First line, Izalontamab brengitecan, Osimertinib, ADC, IZABRIGHT-Lung02
Brief summary
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
DRUGIza-bren
Specified dose on specified days
DRUGOsimertinib
Specified dose on days
DRUGPemetrexed
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Up to approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to approximately 5 years |
| PFS assessed by the investigator as per RECIST v1.1 | Up to approximately 3 years |
| Second Progression-Free Survival (PFS2) as assessed by the Investigator | Up to approximately 5 years |
| Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1 | Up to approximately 3 years |
| Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1 | Up to approximately 3 years |
| Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1 | Up to approximately 3 years |
| Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1 | Up to approximately 3 years |
| Duration of Response (DOR) assessed by the BICR as per RECIST v1.1 | Up to approximately 3 years |
| Duration of Response (DOR) assessed by the investigator as per RECIST v1.1 | Up to approximately 3 years |
Countries
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed