A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore

Trial Details

NCT ID
NCT06452277
Phase
PHASE3
Sponsor
Bayer
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Sevabertinib
  • Pembrolizumab
  • Cisplatin
  • Carboplatin
  • Pemetrexed
Locations (sample)
  • Newport Beach, California, United States|33.61891,-117.92895
  • San Diego, California, United States|32.71571,-117.16472
  • San Francisco, California, United States|37.77493,-122.41942
  • Santa Monica, California, United States|34.01949,-118.49138
  • Fort Lauderdale, Florida, United States|26.12231,-80.14338

Key Eligibility Criteria

  • Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the i…
  • Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squ…
  • Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equa…
  • No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, tra…

For full eligibility, visit ClinicalTrials.gov.

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