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

Qu Biologics

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Biological: QBKPN SSI

Study type

Interventional

Funder types

Industry

Identifiers

NCT02256852

QBKPN-01

Details and patient eligibility

About

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.

Full description

Please refer to summary above.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No 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