Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma

Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma Based on Chemotherapy for Advanced Non-small Cell Lung Squamous Carcinoma Patients：a Randomized Controlled,Open, Multicenter Clinical Study

Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers.

Study Overview

• Status: Unknown
• Conditions: Advanced Lung Squamous Carcinoma
• Intervention / Treatment: Biological: Endostar; Drug: Docetaxel; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhou Xiaolei, sponsor; Phone Number: 0086-02585566666; Email: zhouxiaolei@simcere.com
• Study Contact Backup: Name: Yin Qingfeng, manager; Phone Number: 0086-02585632992; Email: y_qingfeng@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Jinling Hospital
      • Contact: Yin Qingfeng, Manager; Phone Number: 0086013912903257; Email: y_qingfeng@163.com
      • Contact: Zhou Xiaolei, Manager; Phone Number: 0086013776639377; Email: zhouxiaolei@simcere.com
      • Principal Investigator: Song Yong, director
    • Soochow, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Yin Qingfeng, mananger; Phone Number: 08613912903257; Email: y_qingfeng@163.com
      • Contact: Zhou Xiaolei, mananger; Phone Number: 08613776639377; Email: zhouxiaolei@simcere.com
      • Principal Investigator: Huang Jianan, director

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma;
2. According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
3. Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
4. Male or female, age between 18 and 75 years old ;
5. ECOG PS 0~1；
6. Expected survival period ≥ 3 months or more
7. Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
8. Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); AST and ALT acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
9. Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
10. The electrocardiogram (ecg) basicaly normal,the body had no to heal wounds
11. 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.
12. Patients had surgery before,but have more than 4 weeks before the study star, and the patient has recovered;
13. Women with cmpleted uterus before intact in the group within 28 days must have a negative pregnancy test results (unles 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).
14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
15. Sign the informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endostar+Docetaxel+Cisplatin; Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma , and the Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7.	Biological: Endostar; Endostar 30mg continuous intravenous injection pump,d1-d7； Drug: Docetaxel; d4 Docetaxel，75（mg/m2），iv； Drug: Cisplatin; d4，cisplatin，75（mg/m2），iv；
Active Comparator: Docetaxel+Cisplatin; Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma.	Drug: Docetaxel; d4 Docetaxel，75（mg/m2），iv； Drug: Cisplatin; d4，cisplatin，75（mg/m2），iv；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	FS 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, unknow death , or other anti tumor therapy was used.	up to month 36

Secondary Outcome Measures

Outcome Measure	Time Frame
overall remission rate(ORR)	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.
Disease control rate （DCR）	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 survival（OS）	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.

Collaborators and Investigators

• Sponsor: Nanjing NingQi Medicine Science and Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Endostar,Advanced lung squamous carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Docetaxel; Cisplatin; Endostar protein
• Other Study ID Numbers: JSLCG-001