Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01827267 (View complete trial on
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.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
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

Eligibility Criteria

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 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.
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