Clinical trial · Interventional
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
NCT02256852CI-TRIAL-00021026completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QBKPN SSI | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QBKPN SSI
- description
- Individualized maintenance dose administered subcutaneously for 12 weeks
- interventionNames
- Biological: QBKPN SSI
Primary outcomes (1)
- measure
- Safety, tolerability and compliance variables
- timeFrame
- 16 weeks
- description
- Assess the number of adverse events and subject reported data
Secondary outcomes (1)
- measure
- Exploratory variables
- timeFrame
- 16 weeks
- description
- Assess and identify biomarkers associated with immune response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.