Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01827267
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-148
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations and who have received at least one prior cytotoxic chemotherapy regimen.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center
Leena Gandhi, MD, PhD,
Dana-Farber Cancer Institute
Rebecca Heist, MD,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Kelly Masone, 617-632-3383,
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- Aged ≥18 years at the time of signing the informed consent.
- Histologically confirmed diagnosis of NSCLC, advanced (stage IIIB) or metastatic
- Documented somatic ErbB2 (HER2) activating mutation.
- Previous treatment with any investigational agent ≤30 days prior to the initiation of
- 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.