A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity

Status: Completed
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Must have \< 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol

• Disease must be measureable per RECIST 1.1

• At least one prior systemic therapy (adjuvant or palliative)

• 18 years or older

• Life expectancy of greater than 4 weeks

• Adequate ECOG performance status 0 or 1

• Adequate organ function as defined in the protocol

• Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue

Locations
United States
Massachusetts
Beth Isreal Deaconess Medical Center
Boston
Brigham and Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Time Frame
Start Date: 2013-05
Completion Date: 2018-01
Participants
Target number of participants: 13
Treatments
Experimental: Sunitinib
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov

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