Clinical trial · Interventional
A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
NCT01531790CI-TRIAL-00008915completedPhase 1ClinicalTrials.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 is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Centrum | Drug | — | UNRESOLVED |
| Endostar | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar plus pemetrexed/carboplatin
- description
- 21 days as one cycle, for a total of 4-6 cycles
- interventionNames
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Endostar
- Drug: Centrum
Primary outcomes (1)
- measure
- Dose Limiting Toxicity
- timeFrame
- up to 21 days
Secondary outcomes (4)
- measure
- Objective Response Rate
- timeFrame
- up to 6 cycles
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC * At least one measurable lesion (RECIST criteria) * Life expectancy \> 3 months * ECOG performance status 0-2 * Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L * Adequate renal, hepatic and coagulation function * Written informed consent Exclusion Criteria: * With uncontrollable malignant pleural effusion or ascites * Thoracic or abdominal surgery within 28 days prior to study entry * History of cerebral stroke or TIA within 6 months prior to study entry * With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy * Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (\> NYHA class II) * With serious infection (\> NCI CTC grade 2) * Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry * Symptomatic brain metastases * Patient who has epilepsy * History of HIV infection or chronic hepatitis B or C * Allergic to any of the study drugs * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.