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 means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The st

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 Francisco, California, United States|37.77493,-122.41942
  • Fort Lauderdale, Florida, United States|26.12231,-80.14338
  • Orlando, Florida, United States|28.53834,-81.37924
  • Atlanta, Georgia, United States|33.749,-84.38798

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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