Clinical trial · Interventional
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer
NCT01631357CI-TRIAL-00041469CIKcompletedPhase 2 / Phase 3ClinicalTrials.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)
This randomized, multicenter,open-label phase II/III study is to evaluate the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
Conditions
Conditions (2)
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 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIK cell | Biological | — | UNRESOLVED |
| Cisplatin injection | Drug | Cisplatin | ALIAS |
| Gemcitabine Injection | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: CIK+CT
- description
- Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
- interventionNames
- Biological: CIK cell
- Drug: Gemcitabine Injection
- Drug: Cisplatin injection
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: CT
- description
- Arm 2: We design chemotherapy alone as a control arm
- interventionNames
- Drug: Gemcitabine Injection
- Drug: Cisplatin injection
Primary outcomes (1)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Sex: male or female * Age: from 18 to 80 years * Histology: squamous non-small-cell lung cancer * Clinical stage: from stage IIIb to stage IV * Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into this study * Karnofsky performance status: more than 50% * Expected survival: more than 2 months * Laboratory tests results 7 days before the start of treatment: White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25 × ULN * pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment * Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study * Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent Exclusion Criteria: * History of neoplasms: other neoplasms * Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy * History of allergies: allergic to the study drugs * Metastasis: clinical symptoms of brain metastasis * Other clinical trial: the subject received other clinical trial before this study * Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive * Woman: pregnant or lactating women * Compliance: poor compliance * History of neoplasms: other neoplasms
References
Publications (0)
Data not yet available
No reference posted for this study.