Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma
1 other identifier
interventional
400
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2015
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJuly 31, 2015
March 1, 2015
2.6 years
July 17, 2015
July 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Study Arms (2)
Endostar+Docetaxel+Cisplatin
EXPERIMENTALPatients 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.
Docetaxel+Cisplatin
ACTIVE COMPARATORPatients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma.
Interventions
Eligibility Criteria
You may qualify if:
- 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 IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
- 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);
- Male or female, age between 18 and 75 years old ;
- ECOG PS 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); 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);
- Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
- The electrocardiogram (ecg) basicaly 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 star, and the patient has recovered;
- 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).
- Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
- Sign the informed consent.
You may not qualify if:
- 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, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- 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;
- With a bleeding tendency
- Researchers believe that patients should not participate in this test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jinling Hospital
Nanjing, Jiangsu, 210002, China
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215006, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 31, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2017
Study Completion
April 1, 2018
Last Updated
July 31, 2015
Record last verified: 2015-03