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Completed

NCT Number: NCT02256852

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BC Cancer Research Centre

Vancouver, Canada

About this study

Please refer to summary above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QBKPN SSI

Biological

QBKPN SSI is administered subcutaneously for 12 weeks

Primary outcomes

  1. Safety, tolerability and compliance variables

    Time frame: 16 weeks

    Assess the number of adverse events and subject reported data

Secondary outcomes

  1. Exploratory variables

    Time frame: 16 weeks

    Assess and identify biomarkers associated with immune response

Sponsors and collaborators

Lead sponsor

Qu Biologics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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