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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256852
• Other study ID #: QBKPN-01
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2014
• Last updated: February 18, 2016
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Qu Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to summary above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Biological:
• QBKPN SSI
QBKPN SSI is administered subcutaneously for 12 weeks

Locations

Country	Name	City	State
Canada	BC Cancer Research Centre	Vancouver

Sponsors (1)

Lead Sponsor	Collaborator
Qu Biologics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability and compliance variables	Assess the number of adverse events and subject reported data	16 weeks	No
Secondary	Exploratory variables	Assess and identify biomarkers associated with immune response	16 weeks	No