Endostar First-line Treatment of Advanced NSCLC

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Endostar; Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT03123445
• Lead Sponsor: China Medical University, China

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.

Detailed Description

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）

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Primary Completion: 2019-04
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endostar + Gemcitabine and Cisplatin	Endostar	Patients in this group will be given endostar combined with gemcitabine and cisplatine.
Endostar + Gemcitabine and Cisplatin	Gemcitabine	Patients in this group will be given endostar combined with gemcitabine and cisplatine.
Endostar + Gemcitabine and Cisplatin	Cisplatin	Patients in this group will be given endostar combined with gemcitabine and cisplatine.
Gemcitabine and Cisplatin	Gemcitabine	Patients in this group will be given gemcitabine and cisplatine.
Gemcitabine and Cisplatin	Cisplatin	Patients in this group will be given gemcitabine and cisplatine.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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