Clinical trial · Interventional
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
NCT01028729CI-TRIAL-00002875NSCLCunknownPhase 4ClinicalTrials.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 single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
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 (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostar | Drug | — | UNRESOLVED |
| Gemcitabine-Cisplatin chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar with chemotherapy
- description
- All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression.
- interventionNames
- Drug: Endostar
- Drug: Gemcitabine-Cisplatin chemotherapy
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- July 2011
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
- timeFrame
- July 2011
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC * At least one measurable lesion * Age of 18-75 years * Life expectancy \> 3 months * ECOG performance status 0-2 * Adequate hematologic, renal, and hepatic function Exclusion Criteria: * Prior systemic chemotherapy for NSCLC * Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture) * Concurrent anticoagulation therapy * Evidence of bleeding diathesis or coagulopathy * Pregnant or lactating women * Allergic to E.coli preparation
References
Publications (0)
Data not yet available
No reference posted for this study.