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)
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT07680790
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Iza-bren — DRUGSpecified dose on specified days
- Osimertinib — DRUGSpecified dose on days
- Pemetrexed — DRUGSpecified dose on specified days
- Carboplatin — DRUGSpecified dose on specified days
- Cisplatin — DRUGSpecified dose on specified days
Study Details
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
Key Dates
- Start date
- Sep 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 30, 2031
- Completion
- Dec 30, 2031
Study Design
- Enrollment
- 850 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A
- Active Comparator: Arm B
Primary Outcome Measure
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 ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (33)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0212 | Beverly Hills | California | 90211 | Site 0212 |
| Local Institution - 0504 | Fullerton | California | 92835 | Site 0504 |
| Local Institution - 0357 | La Jolla | California | 92093 | Site 0357 |
| Local Institution - 0520 | Pueblo | Colorado | 81003 | Site 0520 |
| Local Institution - 0366 | Orlando | Florida | 32806 | Site 0366 |
| Local Institution - 0519 | Palm Bay | Florida | 32901 | Site 0519 |
| Local Institution - 0210 | Honolulu | Hawaii | 96813 | Site 0210 |
| Local Institution - 0207 | Ottawa | Illinois | 61350 | Site 0207 |
| Local Institution - 0503 | Baltimore | Maryland | 21202 | Site 0503 |
| Local Institution - 0523 | Silver Spring | Maryland | 20904 | Site 0523 |
| Local Institution - 0521 | Edina | Minnesota | 55435 | Site 0521 |
| Local Institution - 0364 | Saint Paul | Minnesota | 55102 | Site 0364 |
| Local Institution - 0403 | St Louis | Missouri | 63110 | Site 0403 |
| Local Institution - 0402 | Omaha | Nebraska | 68198 | Site 0402 |
| Local Institution - 0290 | Lebanon | New Hampshire | 03756 | Site 0290 |
| Local Institution - 0183 | New Brunswick | New Jersey | 08901 | Site 0183 |
| Local Institution - 0153 | New York | New York | 10021 | Site 0153 |
| Local Institution - 0157 | The Bronx | New York | 10461 | Site 0157 |
| Local Institution - 0385 | Charlotte | North Carolina | 28204 | Site 0385 |
| Local Institution - 0438 | Sandusky | Ohio | 44870 | Site 0438 |
| Local Institution - 0404 | Portland | Oregon | 97213 | Site 0404 |
| Local Institution - 0487 | Easton | Pennsylvania | 18045 | Site 0487 |
| Local Institution - 0200 | Sioux Falls | South Dakota | 57105 | Site 0200 |
| Local Institution - 0199 | Memphis | Tennessee | 38120 | Site 0199 |
| Local Institution - 0522 | Beaumont | Texas | 77702 | Site 0522 |
| Local Institution - 0525 | Dallas | Texas | 75246 | Site 0525 |
| Local Institution - 0529 | San Antonio | Texas | 78217 | Site 0529 |
| Local Institution - 0411 | Salt Lake City | Utah | 84112 | Site 0411 |
| Local Institution - 0165 | Fairfax | Virginia | 22031 | Site 0165 |
| Local Institution - 0530 | Fairfax | Virginia | 22031 | Site 0530 |
| Local Institution - 0528 | Winchester | Virginia | 22601 | Site 0528 |
| Local Institution - 0283 | Seattle | Washington | 98104 | Site 0283 |
| Local Institution - 0502 | Morgantown | West Virginia | 26505 | Site 0502 |
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