Endostar First-line Treatment of Advanced NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

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

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endostar + Gemcitabine and Cisplatin

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

Group Type EXPERIMENTAL

Endostar

Intervention Type DRUG

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

Gemcitabine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Gemcitabine and Cisplatin

Patients in this group will be given gemcitabine and cisplatine.

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Interventions

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Endostar

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

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Other Intervention Names

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Recombinant Human Endostatin Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No