The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

checkorphan
Learn more about:
Adenocarcinoma of lung
Related Access Program
Boehringer Ingelheim – Adenocarcinoma of lung
Related Clinical Trial
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer Phase 1/2 Study of CISH Inactivated TILs in the Treatment of NSCLC Prognostic Value of Lung Cancer MicroAnatomy in 3D APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis Therapeutic ResistAnce and Clonal Evolution of ICIs Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Icotinib for Completed Resected IB NSCLC With EGFR Mutation Circulating Tumor DNA in Patients at High Risk for Lung Cancer Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery QUILT-3.017: Study of NEO-201 in Solid Tumors Photodynamic Therapy in Treating Patients With Lung Cancer Vaccine Treatment for Advanced Non-Small Cell Lung Cancer S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC The Tracking Molecular Evolution for NSCLC (T-MENC) Study Phase 1a/1b Study of TPST-1495 Alone and With Pembrolizumab in Subjects With Solid Tumors An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC Feasibility and Safety of Nintedanib in Combination With Nivolumab in Pretreated Patients With Advanced or Metastatic NSCLC of Adenocarcinoma Histology Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma Prospective Radiological Study of HRCT to Predict Pathological Noninvasiveness in NSCLC To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung Lung Cancer Mutation Consortium Protocol The Detection of EGFR Mutations in Liquid Based Cytology Samples NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03) Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR Telomere Biology in Early Adenocarcinoma of the Lung

Brief Title

The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

Official Title

The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR

Brief Summary

      The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with
      cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced
      lung adenocarcinoma patients with wild-type EGFR

Detailed Description

      400 patients with stage IIIB & IV lung adenocarcinoma who had received surgery and
      chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group
      B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles
      of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive
      only Apatinib (continuous) .

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Overall Survival (OS)

Secondary Outcome

 Progression-Free-Survival (PFS)

Condition

Adenocarcinoma of Lung

Intervention

Cytokine-Induced Killer Cells

Study Arms / Comparison Groups

 Apatinib alone
Description:  Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

400

Start Date

July 2015

Completion Date

July 2033

Primary Completion Date

July 2030

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed Lung adenocarcinoma

          -  Wld-type EGFR

          -  Stage IIIB/IV

          -  Failure to prior chemotherapy

          -  Life expectancy of more than 3 months

          -  Tissue sample desired for genomic study

          -  Age ≥ 18 years

          -  Performance status (WHO) < 3

          -  Adequate bone marrow function (absolute neutrophil count>1000/mm^3, platelet count >
             100000/mm^3, hemoglobin > 9gr/mm^3)

          -  Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
             upper limit of normal) and renal function (creatinine < 2mg/dl)

          -  Presence of two-dimensional measurable disease. The measurable disease should not have
             been irradiated

          -  Informed consent

        Exclusion Criteria:

          -  Lung squamous cell carcinoma or other types of Non-Small cell lung cancer

          -  Small cell lung cancer

          -  Have previously received TKIs

          -  Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine
             aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and
             creatinine more than normal limits on 3.0 times

          -  Known or suspected allergy to the investigational agent or any agent given in
             association with this trial

          -  Pregnant or lactating patients

          -  Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or
             TreponemaPallidun (TP) infection

          -  Patients who are suffering from serious autoimmune disease

          -  Patients who had used long time or are using immunosuppressant

          -  Patients who had active infection

          -  Patients who are suffering from serious organ dysfunction

          -  Patients who are suffering from other cancer

          -  Other situations that the researchers considered unsuitable for this study.

          -  Other concurrent uncontrolled illness

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Administrative Informations

NCT ID

NCT02493582

Organization ID

CAA

Responsible Party

Sponsor

Study Sponsor

The First People's Hospital of Changzhou

Study Sponsor

, ,

Verification Date

February 2016