Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
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.
Primary Objectives
- To evaluate the objective response rate (ORR) to sunitinib in never-smokers with lung
cancers that are wild-type for EGFR, KRAS, and ALK in a single-arm phase II trial
Secondary Objectives
- To identify oncogenic alterations underlying sensitivity to sunitinib through performing
nextgeneration sequencing (NGS) of lung cancers treated with sunitinib
- To explore the activity of sunitinib in lung cancers known to harbor a RET
rearrangements and other genomic alterations in targets of sunitinib (e.g. cKIT, PDGFRa,
PDGFRb).
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