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Clinical Trial VICCTHN1307


A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients with Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations

Principal Investigator(s)

Leora Horn


  • Protocol No. VICCTHN1307
  • Open Date: 06/06/2013
  • Staging: Phase II
  • Age Group: Adults
  • Scope: International
  • Objective: The primary objective of this study is to determine the confirmed best overall response rate (ORR = complete response [CR] + partial response [PR]) following treatment with neratinib and neratinib plus temsirolimus in patients with NSCLC carrying known human epidermal growth factor receptor 2 (HER2) activating mutations who have received at least one prior regimen of chemotherapy.
  • Disease Sites: Lung; Non Small Cell
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01827267
  • Secondary Protocol No: PUMA-NER-4201


None Provided.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Aged ≥18 years at the time of signing the informed consent.
• Histologically confirmed diagnosis of NSCLC, advanced (stage IIIB) or metastatic (stage IV).
• Documented somatic ErbB2 (HER2) activating mutation.
Exclusion Criteria:
• Previous treatment with any investigational agent ≤30 days prior to the initiation of investigational products.
• Prior exposure to neratinib or mTOR inhibitor
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.