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

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Biological: QBKPN SSI

• Registration Number: NCT02256852
• Lead Sponsor: Qu Biologics Inc.

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.

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-06
• Study Start: 2014-12
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QBKPN SSI	QBKPN SSI	Individualized maintenance dose administered subcutaneously for 12 weeks

Primary Outcome Measures

Name	Time	Method
Safety, tolerability and compliance variables	16 weeks	Assess the number of adverse events and subject reported data

Secondary Outcome Measures

Name	Time	Method
Exploratory variables	16 weeks	Assess and identify biomarkers associated with immune response

Trial Locations

Locations (1)

BC Cancer Research Centre; 🇨🇦 Vancouver, Canada