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Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Jiangsu Simcere Pharmaceutical Co., Ltd.
Beta Pharma, Inc.
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University

Brief Summary:
This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib is more effective when given with rh-endostatin in NSCLC patients with EGFR activating mutations.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Endostar and icotinib Phase 2

Detailed Description:
  1. Open-label, single-arm, prospective pilot study.
  2. 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).
  3. 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.
  4. Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment.
  5. Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI).
  6. QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment.
  7. All patients who prematurely discontinue treatment for any reason will be followed for survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Other Names:
  • Recombinant Human Endostatin Injection
  • Icotinib Hydrochloride Tablets

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]
  2. Safety: Number of Participants with Adverse Events [ Time Frame: 12 months ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic documentation of non small cell lung cancer, with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation).
  • Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system -Measureable disease
  • Life expectancy of >= 12 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Absolute neutrophil count (ANC) >= 1, 500/mm^3, platelet count >= 100,000/mm^3, hemoglobin >= 9.0 g/dL.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases, cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN.
  • Prothrombin time (PT) =< 1.5 x ULN, partial thromboplastin time (PTT) =< ULN
  • Urine dipstick proteinuria < 2+. Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours.
  • Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only.
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up.
  • Willing to provide tissue and blood samples for correlative research purposes.

Exclusion Criteria:

  • Evidence of bleeding diathesis or coagulopathy.
  • Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
  • Anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • History of hemoptysis.
  • Clinically significant infections as judged by the treating investigator.
  • Other active malignancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT02375022

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China, Zhejiang
Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Qiong Zhao    0571-87236802   
Contact: Ling Peng    0571-87236800   
Sponsors and Collaborators
Zhejiang University
Jiangsu Simcere Pharmaceutical Co., Ltd.
Beta Pharma, Inc.
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Responsible Party: Qiong Zhao, Chief, Department of Thoracic Oncology, Zhejiang University Identifier: NCT02375022    
Other Study ID Numbers: ZYTOP1501
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Endostar protein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents