Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: QBKPN SSI
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
BC Cancer Research Centre
Vancouver, Canada
Status: Recruiting
Start Date
December 2014
Completion Date
June 2016
Sponsors
Qu Biologics Inc.
Source
Qu Biologics Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page