Summary
This study focuses on individuals who have unresectable, locally advanced or metastatic lung cancer with a mutation on the human epidermal growth factor receptor 2 (HER2). HER2 is a protein found on the surface of tumor cells. Unresectable means that the cancer is unable to be removed with surgery. The purpose of the study is to determine whether an experimental drug called trastuzumab deruxtecan is effective and safe for the treatment of unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 19 or 20 mutations as compared to standard-of-care treatment. In some lung cancers, the cancer cells have alterations on the HER2 gene called “mutations”. A mutation in HER2 exons 19 or 20 refers to the specific location of that alteration. Trastuzumab Deruxtecan is a type of anti-cancer drug called an ‘antibody drug conjugate’ (ADC) that targets cancer cells. Standard-of-care treatment in this study will include chemotherapy plus pemetrexed and immunotherapy (pembrolizumab).
Inclusion Criteria
- Participants at least 18 years of age
- Locally advanced not amenable to curative therapy, or metastatic disease
- Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
- Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
Study Location(s)
- Cedars-Sinai Cancer at Beverly Hills (THO) : Amy Oppenheim
- Cedars-Sinai Cancer at SOCC : Amy Oppenheim
More about this Clinical Trial
Full Title
D967SC00001: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations