Clinical trial · Interventional
CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer
An Open-label, Randomized, Controlled Study of Gefitinib Plus Autologous Cytokine-Induced Killer Cell Immunotherapy(CIK)Versus Gefitinib Alone As Second Or Third-Line Treatment in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer
- 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)
Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A:cytokine-induced killer cell +gefitinib | Drug | — | UNRESOLVED |
| Group B:Gefitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Gefitinib combination with CIK cell immunotherapy
- interventionNames
- Drug: Group A:cytokine-induced killer cell +gefitinib
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Gefitinib alone
- interventionNames
- Drug: Group B:Gefitinib
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- up to 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 to 80 years * Histologically or cytologically proven advanced adenocarcinoma non-small-cell lung cancer * Life expectancy more than 12 weeks * Not received EGFR agent or cell immunotherapy before entry into this study * World Health Organization- Eastern Cooperative Oncology Group Performance Status 0-3 * Gefitinib as the second or third line therapy * More than 4 weeks must have completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects * Disease measurable * Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.0×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 75×109/L, Hemoglobin more than 80g/L, Serum total bilirubin less than 1.25 folds of the upper normal limit (ULN), Serum glutamic-oxal (o) acetic transaminase: less than 2.5×ULN, Serum glutamate pyruvate transaminase: less than 2.5×ULN, Serum creatinine: less than 1.25×ULN, Blood urea nitrogen: less than 2×ULN. * Pregnancy test: the test of women of child-bearing period must be negative before entry into this study * Subject must have good compliance and voluntarily to sign a written informed consent Exclusion Criteria: * Acute infection * Uncontrolled concurrent illness: hypersensitiveness, asthma, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious heart valve disease * Psychiatric illness, pharmacological dependence, or other situation that would limit compliance with study requirements * History of other neoplasms * Coagulation disorder and bleeding tendency * Pertinacious hypertension(systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg) after aggressive therapy * Brain metastasis with symptomatic * Severe liver dysfunction * Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, thyroadenitis, et al ) * Patients who diagnosed as virus hepatitis, syphilis or HIV, or other infectious diseases * Employment of corticosteroids or other immunodepressive hormone therapies * With main organs transplantation * Pregnant or lactating women * Known or suspected in patients with severe hypersensitivity to CIK or gefitinib or to any other component of gefitinib * Patients receiving any other investigational agents in 30 days or prepare to participate in other investigation in the clinical period
References
Publications (0)
Data not yet available