Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation

NCT06761976 | Unknown

• 2 other identifiers: 2291322978
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.

Conditions

Advanced Non-small Cell Lung Cancer; Cancer

Interventions

Sevabertinib DRUG

Sevabertinib is self-administered by the patient BID (twice a day) as tablets for oral administration

Also known as: BAY2927088

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent
• Age ≥18 years
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC
• Documented disease progression after treatment with at least one prior systemic therapy for advanced disease
• Documented HER2 activating mutation
• Expected minimum life expectancy of 12 weeks
• Performance status of 0 or 1
• Participants must be able to take oral medication
• Blood test results within certain ranges
• Adequate coagulation as assessed by lab tests or on stable anticoagulation treatment
• Adequate cardiac function
• Negative serum pregnancy test in women of childbearing potential within 72 hours of the first dose
• Ability to receive prescription of loperamide from the treating physician

You may not qualify if:

• Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy
• Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2
• Symptomatic or unstable brain metastases
• Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP
• Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease
• Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation
• Any uncontrolled intercurrent illness or condition including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, ongoing or active infection (including active clinical tuberculosis), renal transplant or psychiatric illness/social situations that would limit compliance
• Pregnancy or lactation
• History of clinically significant cardiac disease

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-06