Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations
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|ClinicalTrials.gov Identifier: NCT02375022|
Recruitment Status : Unknown
Verified March 2015 by Qiong Zhao, Zhejiang University.
Recruitment status was: Recruiting
First Posted : March 2, 2015
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Endostar and icotinib||Phase 2|
- Open-label, single-arm, prospective pilot study.
- Definition of advanced non small cell lung cancer: stage IIIb or IV. EGFR mutation status: activating mutation (defined as deletion 19 or exon 21 L858R mutation).
- Before starting study treatment, computed tomography scans of the chest, B ultrasound of abdomen, 12-lead electrocardiogram, MRI scan of brain, and a bone scan are required.
- Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment.
- Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI).
- QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment.
- All patients who prematurely discontinue treatment for any reason will be followed for survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Efficacy of Rh-Endostatin (Endostar®) in Combination With Icotinib for Advanced Non-Small Cell Lung Cancer With EGFR Mutations|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
Experimental: Endostar and icotinib
Combination of drug: Endostar: 15mg CIV d1-9, Q3w and icotinib: 125mg TID po. If no progressive disease observed, combination treatment will continue until unacceptable toxicity or progressive disease.
Drug: Endostar and icotinib
Endostar and icotinib are used as combination therapy.
- Objective response rate [ Time Frame: 6 months ]
- Progression free survival [ Time Frame: 12 months ]
- Safety: Number of Participants with Adverse Events [ Time Frame: 12 months ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375022