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Sunitinib in Never-Smokers With Lung Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01829217
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : September 4, 2018
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
Geoffrey Oxnard, MD, Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Sunitinib Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
Study Start Date : May 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sunitinib
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Drug: Sunitinib

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months). ]
    Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01829217

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
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Principal Investigator: Geoffrey Oxnard, MD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Geoffrey Oxnard, MD, Dana-Farber Cancer Institute:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Geoffrey Oxnard, MD, Prinicipal Investigator, Dana-Farber Cancer Institute Identifier: NCT01829217    
Other Study ID Numbers: 13-086
First Posted: April 11, 2013    Key Record Dates
Results First Posted: September 4, 2018
Last Update Posted: October 31, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Adenocarcinoma of Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action