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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building
  Irvine, California, United States Recruiting
• University of California, Irvine (UCI) Health - UC Irvine Medical Center
  Orange, California, United States Recruiting
• Shaw Cancer Center
  Edwards, Colorado, United States Recruiting
• Piedmont Healthcare
  Atlanta, Georgia, United States Recruiting
• John B Amos Cancer Center
  Columbus, Georgia, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

+137 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Izalontamab Brengitecan with Osimertinib in EGFR-mutant NSCLC: first-line versus standard options

  This study tests whether adding iza-bren to osimertinib can help people with newly diagnosed EGFR-mutant non-small cell lung cancer, compared with osimertinib alone or osimertinib plus platinum-based chemotherapy.

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• Izalontamab Brengitecan plus Adagrasib in KRAS G12C NSCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.