Endostar First-line Treatment of Advanced NSCLC

Sponsor

China Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03123445

Collaborator

The First Affiliated Hospital of Dalian Medical University (Other), The Second Affiliated Hospital of Dalian Medical University (Other), Liaoning Tumor Hospital & Institute (Other), Shengjing Hospital (Other), General Hospital of Shenyang Military Region (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung cancer and maintenance treatment.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Endostar Drug: Gemcitabine Drug: Cisplatin	Phase 2

Detailed Description

main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS（overall survival）

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study

Anticipated Study Start Date :

Apr 1, 2017

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endostar + Gemcitabine and Cisplatin Patients in this group will be given endostar combined with gemcitabine and cisplatine.	Drug: Endostar Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total Other Names: Recombinant Human Endostatin Injection Drug: Gemcitabine Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total Drug: Cisplatin Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total
Active Comparator: Gemcitabine and Cisplatin Patients in this group will be given gemcitabine and cisplatine.	Drug: Gemcitabine Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total Drug: Cisplatin Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total

Arm

Intervention/Treatment

Experimental: Endostar + Gemcitabine and Cisplatin

Patients in this group will be given endostar combined with gemcitabine and cisplatine.

Drug: Endostar

Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total

Other Names:

Recombinant Human Endostatin Injection

Drug: Gemcitabine

Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total

Drug: Cisplatin

Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total

Active Comparator: Gemcitabine and Cisplatin

Patients in this group will be given gemcitabine and cisplatine.

Drug: Gemcitabine

Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total

Drug: Cisplatin

Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total

Outcome Measures

Primary Outcome Measures

Progression-free Survival (PFS) [Time Frame: up to month 36]
PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used.

Secondary Outcome Measures

ORR [Time Frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.]
overall remission rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma; According to a new IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer.
Must have at least one evaluated lesion,according to the RECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
Male or female, age between 18 and 75 years old ;
ECOG(Eastern Cooperative Oncology Group) PS (performance status ) 0~1；
Expected survival period ≥ 3 months or more
Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
The electrocardiogram (ecg) basically normal,the body had no to heal wounds
No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
Patients had surgery before,but have more than 4 weeks before the study start, and the patient has recovered;
Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
Sign the informed consent.

Exclusion Criteria:

Pregnancy, nursing mothers, or female patients with fertility but no contraception.
Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
Original serious heart disease, including: congestive heart failure, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(CNS) metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
With a bleeding tendency
Researchers believe that patients should not participate in this test.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China Medical University, China
The First Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Dalian Medical University
Liaoning Tumor Hospital & Institute
Shengjing Hospital
General Hospital of Shenyang Military Region

Investigators

Principal Investigator: liu yunpeng, PhD, First Hospital of China Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Yunpeng Liu, Director of Department of Medical Oncology,The First Hospital of China Medical University Affiliation: China Medical University, China, China Medical University, China

ClinicalTrials.gov Identifier:

NCT03123445

Other Study ID Numbers:

CLOG1701

First Posted:

Apr 21, 2017

Last Update Posted:

Apr 21, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Yunpeng Liu, Director of Department of Medical Oncology,The First Hospital of China Medical University Affiliation: China Medical University, China, China Medical University, China

endostar

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2017