Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer | NCT02256852

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

NCT02256852

Sponsor

Qu Biologics Inc.

Status

Completed

Last Update Posted

Feb 22, 2016Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Non-Small Cell Lung Cancer

Interventions

QBKPN SSI

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Sep 30, 2014

First Submission Date that Met QC Criteria

Oct 1, 2014

First Posted Date

Oct 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2016

Last Update Posted Date

Feb 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QBKPN SSI	Experimental	Individualized maintenance dose administered subcutaneously for 12 weeks	Biological: QBKPN SSI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QBKPN SSI	Biological	QBKPN SSI is administered subcutaneously for 12 weeks	QBKPN SSI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dr. Stephen Lam	British Columbia Cancer Agency	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided