Clinical trial · Interventional
Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)
Phase III Study of Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
NCT01124253CI-TRIAL-00003453DengshancompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NP plus recombinant human endostatin
- interventionNames
- Drug: recombinant human endostatin
- type
- NO_INTERVENTION
- label
- vinorelbine plus cisplatin
- interventionNames
- Drug: recombinant human endostatin
Primary outcomes (1)
- measure
- overall survival(OS)
- timeFrame
- five years
Secondary outcomes (2)
- measure
- disease-free survival(DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer, the pathology type includes squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of the 3 types mentioned above. * Stage IB-IIIA non-small cell lung cancer, tumor was completely resected (The type of surgery including lobectomy, left side pneumonectomy,bi-lobectomy). * The time from surgery to first dose of adjuvant chemotherapy are mandatory between 4-8 weeks. * No evidence of tumor relapse prior to adjuvant therapy. * Age 18-70, Eastern Cooperative Oncology Group(ECOG) performance status 0-1. * Normal hematologic function.Renal function , hepatic and cardiac function will be within the acceptable ranges as following:serum bilirubin, aspartate aminotransferase(AST)and alamine aminotransferase(ALT)levels below 1.5 times of normal value. * No history of chemotherapy or radiotherapy; * The patient should have well compliance for chemotherapy and follow up * Informed consent should be obtained before treatment. Exclusion Criteria: * The histological or cytological documents do not match the inclusion criteria. * Right side pneumonectomy or any kind of incompletely resected surgery. * The recruitment time are beyond 8 weeks from surgery. * Any concurrent acute or chronic systemic diseases or psychiatric diseases, which might both increase the risks of the research itself or the medical therapy and influence the research results analysis. The researchers can make a judge for the following conditions to tell whether they are fit for this research:Uncontrolled high blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or congestive heart failure with clinical symptoms within 12 weeks before randomization.Evidence of anemia from electrocardiographic manifestation or heart valve disease with confirmed clinical diagnosis.Clinically significant active infection state due to bacteria, virus and fungi invasion. Patients with grade II arrhythmia, grade II myocardial anemia, grade II abnormal cardiac troponin T, grade II high blood pressure or left ventricle ejection fraction (LVEF) less than 50 percent according to CTC 3.0 are not permitted to enrol the study. * women with pregnant or lactation. * Before enter the group,the patients had other malignant tumors except for non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer. * With allergic constitution or possible allergic reflection to any known research drugs. * Poor compliance. * Not proper for the research according to the researchers' judgment.
References
Publications (1)
- DERIVEDZhou Z, Chen ZW, Yang XH, Shen L, Ai XH, Lu S, Luo QQ. Establishment of a biomarker model for predicting bone metastasis in resected stage III non-small cell lung cancer. J Exp Clin Cancer Res. 2012 Apr 26;31(1):34. doi: 10.1186/1756-9966-31-34. PMID 22537906