Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung adenocarcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer

NCT01631357

Non-small Cell Lung Cancer Squamous Cell Carcinoma

COMPLETED PHASE2/PHASE3

CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

NCT01533727

Non-small Cell Lung Cancer

WITHDRAWN PHASE2

ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

NCT04412616

Advanced EGFR Positive Solid Tumor

RECRUITING PHASE1

D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)

NCT02651441

Lung Cancer Non-small Cell Lung Cancer

UNKNOWN PHASE1/PHASE2

Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer

NCT02573506

Non-small Cell Lung Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is still no great improvement in advanced EGFR wild-type lung adenocarcinoma although great progress was made in treatment of non-small cell lung cancer. It's necessary to explore the treatment mode of this kind of patients. As the progress was made in tumor immunity and immunotherapy, more and more cancer therapists accept the treatment model of chemotherapy combined immunotherapy. And now chemotherapy combined autologous CIK cells is one kind of common treatment model in some countries. Investigators try to evaluate the efficacy and safety of this kind of treatment model in patients with stage Ⅳ naive EGFR wild-type lung adenocarcinoma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CIK combined chemotherapy group

autologous CIK combined chemotherapy group Drugs: platinum combined doublets; After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-indued killer cells are transfused into the vein of patients in one hour.

Group Type EXPERIMENTAL

CIK

Intervention Type BIOLOGICAL

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1. After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-induced killer cells are transfused into the vein of patients in one hour.

chemotherapy

Intervention Type DRUG

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1.

chemotherapy group

platinum combined doublets Drugs: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/ m2，D1-3 or carboplatin AUC=5, D1.

Group Type ACTIVE_COMPARATOR

chemotherapy

Intervention Type DRUG

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CIK

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1. After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-induced killer cells are transfused into the vein of patients in one hour.

Intervention Type BIOLOGICAL

chemotherapy

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

autologous cytokine-induced killer cells platinum combined doublets

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Diagnosed as stage Ⅳ naive EGFR wild-type lung adenocarcinoma by image, tissue and/or cytology; or relapse after operation (if the patient received adjuvant chemotherapy and the interval between the last chemotherapy and relapse is at least six months. The detection method of EGFR mutation is ARMS.
2. EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.
3. There should be at least one measurable lesions (by CT or MRI)
4. No other cancer history ( except skin squamous cell carcinoma after surgery)
5. Age between 18 and 75 years old
6. World health organization- Eastern Cooperative Oncology Group Performance Status 0-1
7. Life expectancy more than 3 months and can be followed-up
8. Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.5×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 80×109/L, Hemoglobin more than 90g/L, Serum total bilirubin less than 1.5 folds of the upper normal limit (ULN), Serum glutamic-oxal

(o) acetic transaminase: less than 2.5×ULN (if there is liver metastasis less than 5×ULN); Serum creatinine: less than 1.0×ULN, Prothrombin time, Active partial thromboplastin time, Fibrinogen, Thrombin time are in normal ranges.
9. Women of child-bearing period must take effective contraceptive measures during all the time of study. During the period of study the results of blood and urine pregnancy test should be negative.
10. Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy.
11. Willing to comply with the ban and constraints for this study protocol specified.
12. Informed consent and willing to participate in this study.

Exclusion Criteria

1. Accepted other study drugs 30 days before the beginning of this study.
2. Brain metastases with clinical symptoms ( with exception of being controlled after radiation)
3. Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment
4. Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection
5. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not be coped with study treatment and monitoring requirements.
6. Known allergy to any kind of component of study drugs
7. Active rheumatic diseases
8. Organ transplant recipients
9. Poor compliance
10. Pregnant women
11. Lactating women

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No