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

Lung Adenocarcinoma Clinical Trial

Official title:

Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma: A Prospective, Randomised, Open, Multicenter Phase Ⅱ Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02621333
• Other study ID #: HenanCH003
• Status: Terminated
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2020
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 280
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Diagnosed as stage ? 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

Biological:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	ZhengZhou	Henan

Sponsors (15)

Lead Sponsor

Collaborator

Henan Cancer Hospital

150th Hospital of PLA, Anyang Regional Hospital, First Affiliated Hospital of Nanyang Medical College, First People's Hospital of Shangqiu, Hebei Medical University Fourth Hospital, Henan Provincial People's Hospital, Jiaozuo Tumor Hospital, Nanyang Central Hospital, Puyang Oil Field General Hospital, Shanxi Dayi Hospital, Shenma Medical Group General Hospital, Tangshan People's Hospital, The 152th Central Hospital of PLA, Xinyang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Li R, Wang C, Liu L, Du C, Cao S, Yu J, Wang SE, Hao X, Ren X, Li H. Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study. Cancer Immunol Immunother. 2012 Nov;61(11):2125-33. doi: 10.1007/s00262-012-1260-2. Epub — View Citation

Wang S, Wang Z. Efficacy and safety of dendritic cells co-cultured with cytokine-induced killer cells immunotherapy for non-small-cell lung cancer. Int Immunopharmacol. 2015 Sep;28(1):22-8. doi: 10.1016/j.intimp.2015.05.021. Epub 2015 May 23. Review. — View Citation

Zhong R, Teng J, Han B, Zhong H. Dendritic cells combining with cytokine-induced killer cells synergize chemotherapy in patients with late-stage non-small cell lung cancer. Cancer Immunol Immunother. 2011 Oct;60(10):1497-502. doi: 10.1007/s00262-011-1060- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival time	overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months	from the day of randomization to the day of death, up to 36 months
Secondary	time to progression	time to progression points to from date of randomization until the date of first documented progression, up to 24 months	from the day of randomization to the day of first detecting progression, up to 24 months
Secondary	objective response rate	the partion of overall remission in total proportion	one year