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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02256852

Enrollment

Registered

2014-10-06

Start date

2014-12-31

Completion date

2015-11-30

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

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.

Interventions

BIOLOGICALQBKPN SSI

QBKPN SSI is administered subcutaneously for 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026