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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2014
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFebruary 22, 2016
February 1, 2016
11 months
September 30, 2014
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety, tolerability and compliance variables
Assess the number of adverse events and subject reported data
16 weeks
Secondary Outcomes (1)
Exploratory variables
16 weeks
Study Arms (1)
QBKPN SSI
EXPERIMENTALIndividualized maintenance dose administered subcutaneously for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Cancer Research Centre
Vancouver, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Stephen Lam
British Columbia Cancer Agency
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 6, 2014
Study Start
December 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
February 22, 2016
Record last verified: 2016-02