Sunitinib in Never-Smokers With Lung Adenocarcinoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01829217 (View complete trial on
DFCI Protocol ID: 13-086


This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved sunitinib for your type of cancer. Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking certain protein signals within the cell. Because sunitinib works differently from standard intravenous chemotherapies, we call it a "targeted therapy." This drug has also been used in other research studies and information from those other research studies suggests that this agent may help to slow the growth of some NSCLC tumors. In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors from growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously been found to be more sensitive to other kinds of oral targeted therapies. This study will focus specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known cancer gene (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100 cigarettes in their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET gene.


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

Overall PI:
Geoffrey Oxnard, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Daniel Costa, MD, Beth Israel Deaconess Medical Center
Rebecca Heist, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer - Adenocarcinoma histology of any variant, including adenosquamous histology - Wild-type for mutations in EGFR, KRAS and ALK - < 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement - Measurable disease - At least one prior systemic therapy (adjuvant or palliative) - Life expectancy of greater than 4 weeks - Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue Exclusion Criteria: - Pregnant or breastfeeding - Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier - Radiation therapy within 2 weeks prior to entering study - Major surgery within 4 weeks prior to entering the study - Receiving any other investigational agents - Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids - History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib - Use of certain inhibitors and inducers of CYP3A4 - Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry - History of significant bleeding disorder unrelated to cancer - Poorly controlled hypertension - Severe cardiovascular disease - Prolongation of corrected QT interval - History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer - HIV positive on combination antiretroviral therapy
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