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NCT07100080

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy With or Without Amivantamab for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

StatusRecruiting
PhasePhase 2/3
Primary completion (estimated)
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Record History

All 24 versions: 24 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 4 words Show 4 more changesShow less
    • Enrollment increased: 500 → 661 participants
    • Interventions modified
    • Study sites revised (187)
    • Study title expanded, about 5 words
  2. Study sites: 185 to 187
  3. Eligibility criteria expanded, about 8 words
    • Study sites: 186 to 185
  4. Study sites revised (186)v21
  5. Study sites revised (186)v20
  6. Study sites revised (186)v19
  7. Primary completion pushed from Sep 15, 2028 to Dec 15, 2028
    • Enrollment reduced: 596 → 500 participants
    • Study completion moved earlier from May 15, 2031 to Nov 15, 2030
    • Study sites revised (186)
    v18
  8. Study sites revised (186)v17
  9. Study sites revised (186)v16
  10. Study sites: 185 to 186v15
  11. Study sites revised (185)v14
  12. Study sites: 184 to 185v13
  13. Study sites revised (184)v12
  14. Study sites revised (184)v11
  15. Study sites revised (184)v10
  16. Study sites revised (184)v9
  17. Study sites revised (184)v8
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 181 to 184
    • Start date changed from estimate of Oct 15, 2025 to Nov 5, 2025
    v7
  19. Study sites: 180 to 181v6
  20. Study sites: 176 to 180v5
  21. Study sites: 174 to 176v4
  22. Study sites: 153 to 174v3
  23. Study sites: 148 to 153v2
  24. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Recommended Phase 3 Dose (RP3D) of BMS-986507
Timeframe: Approximately 3 months after the first dose
Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Timeframe: Up to 3 years

Secondary (8)

Objective Response (OR) Assessed by RECIST v1.1 per BICR
PFS Assessed by RECIST v1.1 per BICR
Overall Survival (OS)
PFS Assessed by RECIST v1.1 per investigator assessment
OR Assessed by RECIST v1.1 per BICR
Show 3 moreShow less
Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR
Duration of Response (DOR) Assessed by RECIST v1.1 per BICR
Time To Response (TTR) Assessed by RECIST v1.1 per BICR

Arms and interventions

Arm AExperimental
Arm BExperimental
Arm CActive comparator
Arm DExperimental
Arm EActive comparator

Drugs: Iza-bren, Carboplatin, Cisplatin, Pemetrexed, Amivantamab

Sites

187 sites in 25 countries

United States 28, China 20, Japan 16, Germany 14, France 11, Spain 10, India 9, Italy 8, Romania 8, South Korea 8, Taiwan 6, Belgium 5, Canada 4, Colombia 4, Greece 4, Mexico 4, Thailand 4, United Kingdom 4, Argentina 3, Chile 3, Netherlands 3, Norway 3, Poland 3, Switzerland 3, Singapore 2