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Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer

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: NCT02256852
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Qu Biologics Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: QBKPN SSI Phase 2

Detailed Description:
Please refer to summary above.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label,Single Arm,Exploratory Study to Evaluate the Safety,Tolerability,Compliance and MOA,of QBKPN SSI in Subjects With 2 or More Second Primary Pre-invasive/Invasive Adenocarcinoma Following Surgical Resection of Stage I NSCLC
Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: QBKPN SSI
Individualized maintenance dose administered subcutaneously for 12 weeks
 Biological: QBKPN SSI
QBKPN SSI is administered subcutaneously for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Safety, tolerability and compliance variables [ Time Frame: 16 weeks ]
    Assess the number of adverse events and subject reported data


Secondary Outcome Measures :
  1. Exploratory variables [ Time Frame: 16 weeks ]
    Assess and identify biomarkers associated with immune response


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

Inclusion Criteria:

  • Male or female who is at or above the age of consent
  • Histologically confirmed original diagnosis of lung cancer
  • Life expectancy greater than 12 months
  • ECOG performance status 0, 1, or 2 at screening
  • Female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug
  • Male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug

Exclusion Criteria:

  • Extra-thoracic lung cancer progression
  • Any active malignancies
  • Any uncontrolled or major organ dysfunction
  • Any past or current radiation or systemic therapies for the treatment of lung cancer
  • Known HIV infection or other immunosuppressive disorder
  • Concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02256852


Locations
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Canada
BC Cancer Research Centre
Vancouver, Canada
Sponsors and Collaborators
Qu Biologics Inc.
Investigators
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Principal Investigator: Dr. Stephen Lam British Columbia Cancer Agency
More Information
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Responsible Party: Qu Biologics Inc.
ClinicalTrials.gov Identifier: NCT02256852    
Other Study ID Numbers: QBKPN-01
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms