Clinical trial · Interventional
Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
NCT01192230CI-TRIAL-00003921unknownPhase 2ClinicalTrials.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)
The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Endostatins | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Response rate
- timeFrame
- six weeks
- measure
- Progression free survival
- timeFrame
- six weeks
- measure
- Overall survival
- timeFrame
- three months
Secondary outcomes (1)
- measure
- Quality of Life
- timeFrame
- six weeks
- description
- EORTC QLQ-C30(v3.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer * ≥ 18 years old * patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled * At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools * have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy * ECOG 0-2 * Expected life time longer than 3 months * Normal laboratory values: * leucocyte≥ 4×109/L * neutrophil≥ 1.5×109/L * platelet≥90×109/L * Hemoglobin≥ 9g/L * ALT and AST ≤3×ULN (≤5×ULN if liver metastasis) * serum creatinine\<1.5 mg/dl * bilirubin \<1.5×ULN * No allergy to biological drug * Sign the consent forms Exclusion Criteria: * Patients who have previously received Docetaxel or anti-VEGF inhibitors * Severe symptomatic heart disease * Female patients during their pregnant and lactation period, or patients without contraception * Severe uncontrolled infection * Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor * Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ * Patients have accepted other clinical trials
References
Publications (0)
Data not yet available
No reference posted for this study.