Non-Small Cell Lung Cancer
Conditions
Keywords
Epidermal Growth Factor Receptor, Tyrosine Kinase Inhibitors, Osimertinib, Standard of Care, Lung Neoplasms, Antineoplastic Agents, Izalontamab brengitecan, Iza-bren, BL-B01D1, Carboplatin, Cisplatin, Pemetrexed
Brief summary
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
DRUGIza-bren
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
DRUGPemetrexed
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
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase 3 Dose (RP3D) of BMS-986507 | Approximately 3 months after the first dose | Phase 2 |
| Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) | Up to 3 years | Phase 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) Assessed by RECIST v1.1 per BICR | Up to 3 years | Phase 2 |
| PFS Assessed by RECIST v1.1 per BICR | Up to 3 years | Phase 2 |
| Overall Survival (OS) | Up to 5 years | Phase 3 |
| PFS Assessed by RECIST v1.1 per investigator assessment | Up to 3 years | Phase 3 |
| OR Assessed by RECIST v1.1 per BICR | Up to 3 years | Phase 3 |
| Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR | Up to 3 years | Phase 3 |
| Duration of Response (DOR) Assessed by RECIST v1.1 per BICR | Up to 3 years | Phase 3 |
| Time To Response (TTR) Assessed by RECIST v1.1 per BICR | Up to 3 years | Phase 3 |
Countries
Argentina, Belgium, Canada, Chile, China, Colombia, France, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, 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