NCT02513355

Brief Summary

Research purpose: Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Last Updated

August 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

July 17, 2015

Last Update Submit

July 31, 2015

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer,Endostar

Outcome Measures

Primary Outcomes (1)

  • PFS（progression-free survival）

    PFS is refers to the patients randomly into group to the date of any objective records of patients with tumor progression or death time.

    Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

Secondary Outcomes (3)

  • ORR（Objective Response Rate）

    1 weeks before treatment, Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

  • DCR(disease control rate)

    Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

  • OS（overall survival）

    Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

Study Arms (2)

NP(Changchun marina+cisplatin)+Endostar

EXPERIMENTAL

Patients in this group will be given conventional chemotherapy medicine,NP plan (Changchun marina+cisplatin)recommended by treatment guidelines for Advanced non small cell lung cancer. Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles;Changchun marina;25mg/m2,d1 and d8,cisplatin 80mg/m2,d1, q21d×4

Biological: EndostarDrug: Changchun marinaDrug: cisplatin

TP(Taxol+cisplatin or parapl) +Endostar

EXPERIMENTAL

Patients in this group will be given conventional chemotherapy medicine,TP(Taxol+cisplatin)recommended by treatment guidelines for Advanced non small cell lung cancer. Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles; Taxol;135-175mg/m2,d1,cisplatin or parapl 75mg/m2,d1,q21d×4.

Biological: EndostarDrug: cisplatinDrug: TaxolDrug: parapl

Interventions

EndostarBIOLOGICAL

Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles

NP(Changchun marina+cisplatin)+EndostarTP(Taxol+cisplatin or parapl) +Endostar
Changchun marinaDRUG

25mg/m2,d1 and d8,q21d×4

NP(Changchun marina+cisplatin)+Endostar
cisplatinDRUG

80mg/m2,d1, q21d×4

NP(Changchun marina+cisplatin)+EndostarTP(Taxol+cisplatin or parapl) +Endostar
TaxolDRUG

135-175mg/m2,d1,q21d×4

TP(Taxol+cisplatin or parapl) +Endostar
paraplDRUG

AUC=5-6,d1,q21d×4

TP(Taxol+cisplatin or parapl) +Endostar

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic confirmation cytology or not in patients undergoing single sputum cytology in the diagnosis of patients with non-small cell lung cancer;
  • according to a new IASLC2009 lung cancer TNM stages judged the preious untreated stage IIIB or IV non-small cell lung cancer (with the exception of EGFR/ALK mutations type);
  • must have at least one according to the RRECIST version 1.1 standard judgment to evaluate lesions (at least 10 mm, maximum diameter on spiral CT plain CT longest diameter at least 20 mm);
  • male or female, age 18 and 75 years old or less or more;
  • ECOG PS 0 \~ 1 minute;
  • is expected to survive period for 3 months or more,
  • enough blood function: absolute neutrophil count (ANC) or 2 x 109 / L and the platelet count 100 x 109 / L or higher acuity 9 g/dL and hemoglobin;
  • Liver function enough: upper limit of total bilirubin acuities were normal (ULN); AST and ALT acuities were 2.5 times the upper limit of normal (ULN); Alkaline phosphatase 5 times the upper limit of normal or less (ULN);
  • enough renal function, serum creatinine or less normal limit (ULN) or calculated creatinine clearance or 60 mL/min.
  • basic normal ecg, had on the body to heal wounds;
  • always not received anti-tumor drug therapy, or always only for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but to study treatment has ended more than six months at the beginning;
  • ever had had surgery patients, request to study treatment began to have more than 4 weeks, and the patient has recovered;
  • a complete uterus of female in the group within 28 days before the study must have a negative pregnancy test results (except amenorrhea has 24 months). If the pregnancy test from the first time for more than 7 days, is the need for urine pregnancy test validation (within 7 days before the first delivery).
  • prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
  • signed informed consent.

You may not qualify if:

  • pregnancy, nursing mothers, or fertility but not women using contraception;
  • the existing serious acute infection, and not be controlled; Or fester sex and chronic infection, wound in delay no more;
  • the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
  • is not easy to control nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious symptoms in cranial hypertension or nerve spirit;
  • with bleeding tendency;
  • other researchers believe that patients should not participate in this test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Taizhou People's Hospital

Nanjing, Jiangsu, 225499, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

endostar proteinCisplatinPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Han gaohua, PI

    China:Taizhou people's hospital

    STUDY CHAIR

Central Study Contacts

Yin Qingfeng, manager

CONTACT

0086-025-85632992y_qingfeng@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 31, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2017

Last Updated

August 4, 2015

Record last verified: 2015-02

Locations

CN(1)