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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Biological: QBKPN SSI

Detailed Description

Please refer to summary above.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada
    • BC Cancer Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, tolerability and compliance variables	Assess the number of adverse events and subject reported data	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory variables	Assess and identify biomarkers associated with immune response	16 weeks

Collaborators and Investigators

• Sponsor: Qu Biologics Inc.
• Investigators: Principal Investigator: Dr. Stephen Lam, British Columbia Cancer Agency

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 1, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: QBKPN-01