CA244-0010 (IZABRIGHT-Lung01): Phase 2/3 study of Izalontamab Brengitecan in EGFR-mutated NSCLC

• Research type

  Research Study

• Full title

  IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

• IRAS ID

  1006902

• Contact name

  GSM-CT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb Services Unlimited Company

• Eudract number

  2025-521908-22

• Clinicaltrials.gov Identifier

  NCT07100080

• Research summary

  IZABRIGHT-Lung01 (CA244-0010) is a global phase 2/3 clinical trial testing the effectiveness of Izalontamab Brengitecan (BMS-986507, iza-bren) in patients with advanced NSCLC (non-squamous) that has an EGFR mutation and has worsened after failure of EGFR (epidermal growth factor receptor) - TKI (tyrosine kinase inhibitors) therapy. Approx. 596 patients will take part in the study globally, including in the UK.
  The study has three parts (screening, treatment and follow-up) and two stages (phase 2 and phase 3).
  In the Phase 2 study, two doses of iza-bren will be compared against each other to find the optional dose. Participants will be randomly assigned to one of three groups: Arm A (iza-bren at a dose level 1) Arm B (iza-bren at a dose level 2) or control Arm C (pemetrexed +platinum of physician’s choice followed by pemetrexed maintenance). Once enough participants have completed this phase to select the better iza-bren dose, the study will move to Phase 3.

  In the Phase 3 study, the optimal dose of iza-bren chosen in the Phase 2 study will be compared with standard-of-care chemotherapy to see which one of these two treatments better slows cancer growth. Participants will be randomly assigned to one of two groups: Arm D (iza-bren selected dose) or control Arm E (study doctor’s choice of chemotherapy, same as in Phase 2).

  Participants (18 years or older) will receive treatment until the cancer progress or side effects become too severe. After stopping treatment, participants will be monitored in-person for side effects for about 30 days and then contacted remotely about every 12 weeks for long-term follow-up. Total study duration is expected to be approx. 5 years for a participant.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  25/SC/0300

• Date of REC Opinion

  28 Nov 2025

• REC opinion

  Further Information Favourable Opinion