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
- 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
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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.
• Previous treatment with any investigational agent ≤30 days prior to the initiation of investigational products.
• Prior exposure to tyrosine kinase inhibitor including neratinib, lapatinib, and afatinib (excluding dacomitinib), or mTOR inhibitor.
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.