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

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 Phase 3 trial compares izalontamab brengitecan in combination with osimertinib to osimertinib alone or to osimertinib plus platinum-based chemotherapy in patients with untreated locally advanced or metastatic EGFR-mutant NSCLC. Eligible participants have identifiable EGFR-sensitizing mutations, measurable disease, and good performance status, and will be monitored for tumor response and safety. The study uses a randomized design to determine if the combination improves outcomes over current standard regimens. Primary endpoints typically include progression-free survival and overall survival, with secondary endpoints assessing response rate and safety. Enrollment is limited to select institutions in California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)
* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator
* Participants must have ECOG Performance Status 0-1

Exclusion Criteria:

* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression
* Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis
* Participants must not have clinically significant cardiac disease
* Other protocol-defined inclusion/exclusion criteria apply.

Where it's running

• Rocky Mountain Cancer Centers
  Boulder, Colorado, United States Recruiting
• Cancer Care Centers of Brevard - Rockledge
  Palm Bay, Florida, United States Recruiting
• Washington University School Of Medicine
  St Louis, Missouri, United States Recruiting
• Texas Oncology
  Beaumont, Texas, United States Recruiting
• Texas Oncology - DFW
  Dallas, Texas, United States Recruiting
• Texas Oncology - San Antonio
  San Antonio, Texas, United States Recruiting

+155 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.

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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.