Clinical trial · Interventional
Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression
NCT02350361CI-TRIAL-00016729unknownPhase 2 / Phase 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)
Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Recombinant human endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endostar Arm
- description
- Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14
- interventionNames
- Drug: Recombinant human endostatin
- type
- ACTIVE_COMPARATOR
- label
- Standard Arm
- description
- Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Objective Responese Rate
- timeFrame
- in two months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy. * Life expectancy of at least three (3) months after the start of administration of the investigational drug. * Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2. * Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and \>=10 mm. * Patient received at least 6 months EGFR-TKI and show tumor progress * Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy * Patient signed consent form and adherence and geographic location are liable to follow up Exclusion Criteria: * CNS metastasis * Active infection * Bleeding tendency or blood coagulation dysfunction * History of neurological or psychiatric disorders, including epilepsy, or dementia * Pregnancy or breast-feeding women * Organ transplant long-term use of immunosuppressive drugs * Arrhythmia need anti-arrhythmic treatment or other risk of heart disease * Use other targeted drugs during the research * Other conditions may not allowed to join in this study according to the researcher's judgment
References
Publications (0)
Data not yet available
No reference posted for this study.