Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma

Learn more about:
Related Clinical Trial
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

Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma

Official Title

Recombinant Human Endostatin Durative Transfusion Combined With Pemetrexed Plus Cisplatin or Carboplatin in the First-line Treatment of Advanced Lung Adenocarcinoma With Wild-type EGFR or ALK-negative

Brief Summary

      The purpose of this study is to discuss the efficacy and safety of recombinant human
      endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin
      or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type
      EGFR or ALK-negative,compared with chemotherapy without endostar.
    

Detailed Description

      With the progress of molecular biology and translational medical research, the treatment of
      advanced non-small cell lung cancer goes into the era of personalized medicine. Lung
      adenocarcinoma accounts for about 50% of non-small cell lung cancer.In recent years, although
      individualized targeted therapy in lung adenocarcinoma progress by leaps and bounds, but the
      research of wild-type EGFR or ALK-negative lung adenocarcinoma is extremely lag, lack of
      clinically effective targeted drugs.As time goes on,almost all of the EGFR-TKI treatment of
      lung adenocarcinoma will be resistant one day,and patients need other treatments, such as
      chemotherapy.Currently, chemotherapy is still the main treatment for advanced lung
      adenocarcinoma with EGFR wild-type and unkown.Many researches has reported that:endostar
      combined with chemotherapy in patients with advanced NSCLC can significantly improve the
      patient's RR,TTP and did not increase the adverse effects of chemotherapy.Recently,endostar
      durative intravenous transfusion has been widely accept and use because of the lower
      toxicity.The purpose of our study was to discuss the efficacy and safety of endostard
      durative intravenous transfusion combined with chemotherapy.In our study,Patients with Ⅲb/Ⅳ
      lung adenocarcinoma were divided into two groups randomly,one group was treated with endostar
      durative intravenous transfusion combined with chemotherapy,while the other group with
      chemotherapy pemetrexed plus cisplatin or carboplatin only.In the end,PFS,ORR,DCR and OS were
      compared between these two groups.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

progression free survival

Secondary Outcome

 objective response rate

Condition

Adenocarcinoma of Lung

Intervention

recombinant human endostatin

Study Arms / Comparison Groups

 endostar and chemotherapy group
Description:  recombinant human endostatin(endostar) injection was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 per one day,every 21 days of a cycle,combined with pemetrexed plus cisplatin or carboplatin.

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

Drug

Estimated Enrollment

100

Start Date

June 2016

Completion Date

December 2018

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          -  1) histologically confirmed (patients not receiving a single sputum cytology
             diagnosis) non-small cell lung cancer patients,with wild-type EGFR and ALK-negative;
             2) According to IASLC2009 new TNM staging of lung cancer stage ⅢB or Ⅳ, previously
             untreated or relapsed after 1 year of lung cancer resection; 3) have at least one
             evaluable lesions,according to version 1.1 of the standard in accordance with a
             judgment RECIST(longest diameter on a spiral CT at least 10mm,on a regular CT longest
             diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6)
             expected survival at least 3 months; 7) adequate hematological function: absolute
             neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and
             hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than
             upper limit of normal (ULN); AST and ALT less than 2.5 times upper limit of normal
             (ULN); alkaline phosphatase less than 5 times the upper limit of normal (ULN); 9)
             adequate renal function: serum creatinine less than upper limit of normal (ULN) or
             calculated creatinine clearance at least 60 mL/min; 10) ECG is normal, there is no
             non-healing wounds on the body; 11) had not received previous treatment anticancer
             drugs, or had only received for previous non-metastatic tumors adjuvant or neoadjuvant
             chemotherapy, but when you start to study treatment has ended more than 6 months; 12)
             have conducted previous surgery patients required to study treatment was started more
             than four weeks, and the patient had recovered; 13) have an intact uterus in women
             prior to enrollment in the study must have a negative pregnancy test result (unless it
             is already 24 months of amenorrhea) within 28 days. If the pregnancy test from the
             first administration more than seven days, urine pregnancy test is required for
             authentication (less than 7 days before the first dose); 14) previous to biological
             agents, particularly E.coli genetically engineered products without serious allergic
             reactions; 15) signed informed consent.

        Exclusion Criteria:

          -  1) pregnancy, breast-feeding women, or female patients of childbearing potential but
             did not take contraceptive measures;2) existing severe acute infection and is not
             controlled; or purulent and chronic infection, delayed healing wounds; 3) the original
             severe heart disease, including congestive heart failure, uncontrolled high-risk
             arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and
             resistant hypertension; 4) suffering from neurological and psychiatric diseases or
             mental disorders is not easy to control, poor compliance, and can not be described
             with treatment responders; primary brain or central nervous metastasis disease has not
             been controlled, with significant cranial hypertension or neuropsychiatric symptoms;
             5) have bleeding tendencies; 6) other researchers believe that patients should not
             participate in the present trial.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Lejie Cao, professor, , [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02804646

Organization ID

20160606


Responsible Party

Sponsor

Study Sponsor

Anhui Provincial Hospital


Study Sponsor

Lejie Cao, professor, Principal Investigator, Anhui Provincial Hospital


Verification Date

June 2016