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Izalontamab brengitecan versus platinum-pemetrexed for EGFR‑mutated non‑small cell lung cancer after EGFR TKI failure

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

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT07100080

This trial tests whether izalontamab brengitecan works better than platinum‑pemetrexed chemotherapy for people with EGFR‑mutated non‑small cell lung cancer that has progressed after third‑generation EGFR TKI treatment.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment596 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsosimertinib, furmonertinib, lazertinib, chemotherapy, Izalontamab
Locations186 sites (Irvine, California and 185 other locations)
Trial IDNCT07100080 on ClinicalTrials.gov

What this trial studies

This is a randomized, phase 2/3 interventional trial comparing the antibody–drug conjugate izalontamab brengitecan (BMS‑986507) to standard platinum‑pemetrexed chemotherapy in patients with non‑squamous EGFR‑mutated NSCLC after progression on a third‑generation EGFR TKI. Eligible participants must have a sensitizing EGFR mutation (for example exon 19 deletion or L858R) and be suitable for platinum‑based doublet chemotherapy. The study will enroll patients at multiple US sites and administer IV investigational therapy or standard platinum plus pemetrexed according to protocol schedules. Key safety and efficacy outcomes will be measured across the phase 2 and phase 3 portions to compare response, progression, and tolerability.

Who should consider this trial

Good fit: Adults with non‑squamous NSCLC harboring sensitizing EGFR mutations whose disease progressed on a third‑generation EGFR TKI and who are eligible for platinum‑pemetrexed are the intended candidates.

Not a fit: People with squamous histology, inadequate organ or bone marrow function, leptomeningeal metastases or spinal cord compression, or those otherwise ineligible for a platinum doublet are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a more effective treatment option that delays disease progression or improves survival compared with standard platinum‑pemetrexed chemotherapy.

How similar studies have performed: Other antibody–drug conjugates have shown activity in lung cancer, but direct head‑to‑head comparisons of izalontamab brengitecan versus platinum‑pemetrexed in this EGFR‑mutant, post‑TKI setting are novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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/exclusion criteria apply.

Where this trial is running

Irvine, California and 185 other locations

+136 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerEpidermal Growth Factor ReceptorTyrosine Kinase InhibitorsOsimertinibStandard of CareLung NeoplasmsAntineoplastic AgentsIzalontamab brengitecan
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.