Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01829217
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : September 3, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Geoffrey Oxnard, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 9, 2013
First Posted Date  ICMJE April 11, 2013
Results First Submitted Date  ICMJE January 30, 2018
Results First Posted Date  ICMJE September 3, 2018
Last Update Posted Date October 31, 2018
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
Evaluate Objective Response Rate to Sunitinib [ Time Frame: 2 years ]
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
Change History Complete list of historical versions of study NCT01829217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
  • Identify Oncogenic Alterations [ Time Frame: 2 years ]
    To identify oncogenic alterations underlying sensitivity to sunitinib through performing next-generation sequencing (NGS) of lung cancers treated with sunitinib
  • Explore Activity of Sunitinib in Lung Cancers with RET Rearrangement [ Time Frame: 2 years ]
    To explore the activity of sunitinib in lung cancers known to harbor a RET rearrangement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib in Never-Smokers With Lung Adenocarcinoma
Official Title  ICMJE A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
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.

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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Sunitinib
Study Arms  ICMJE Experimental: Sunitinib
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Intervention: Drug: Sunitinib
Publications * Wu H, Shih JY, Yang JC. Rapid Response to Sunitinib in a Patient with Lung Adenocarcinoma Harboring KIF5B-RET Fusion Gene. J Thorac Oncol. 2015 Sep;10(9):e95-e96. doi: 10.1097/JTO.0000000000000611.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2017)
13
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2013)
35
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01829217
Other Study ID Numbers  ICMJE 13-086
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geoffrey Oxnard, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Geoffrey Oxnard, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP