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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
QBKPN SSI
Sponsored by
Qu Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Cancer Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QBKPN SSI

Arm Description

Individualized maintenance dose administered subcutaneously for 12 weeks

Outcomes

Primary Outcome Measures

Safety, tolerability and compliance variables
Assess the number of adverse events and subject reported data

Secondary Outcome Measures

Exploratory variables
Assess and identify biomarkers associated with immune response

Full Information

First Posted
September 30, 2014
Last Updated
February 18, 2016
Sponsor
Qu Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02256852
Brief Title
Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qu Biologics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Please refer to summary above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QBKPN SSI
Arm Type
Experimental
Arm Description
Individualized maintenance dose administered subcutaneously for 12 weeks
Intervention Type
Biological
Intervention Name(s)
QBKPN SSI
Intervention Description
QBKPN SSI is administered subcutaneously for 12 weeks
Primary Outcome Measure Information:
Title
Safety, tolerability and compliance variables
Description
Assess the number of adverse events and subject reported data
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Exploratory variables
Description
Assess and identify biomarkers associated with immune response
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Stephen Lam
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Research Centre
City
Vancouver
Country
Canada

12. IPD Sharing Statement

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

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