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Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT01926171
Recruitment Status : Unknown
Verified July 2015 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 20, 2013
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Icotinib plus WBRT Phase 4

Detailed Description:
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
Study Start Date : June 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Icotinib plus WBRT
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.
Drug: Icotinib plus WBRT
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.
Other Names:
  • Commana
  • BPI-2009




Primary Outcome Measures :
  1. Objective response rate of intracranial lesions [ Time Frame: 8 weeks ]
    Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.


Secondary Outcome Measures :
  1. Objective response rate of extracranial lesions [ Time Frame: 8 weeks ]
    Number of participants with an objective response of extracranial lesions. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.

  2. Progression-free survival of intracranial lesions [ Time Frame: 3-6 months ]
    All cause progress or mortality

  3. Safety and tolerability [ Time Frame: 6-12 months ]
    All cause adverse events (AEs) and serious adverse events (SAEs)



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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
Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
  • Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
  • No other metastases except for brain metastases.

Exclusion Criteria:

  • Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
  • CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

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 ClinicalTrials.gov identifier (NCT number): NCT01926171


Contacts
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Contact: Wei Zhu, MD 86-18686111667

Locations
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China, Inner Mongolia
Baotou Central Hospital Recruiting
Baotou, Inner Mongolia, China
Contact: Wei Zhu, MD         
Principal Investigator: Wei Zhu, MD         
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Wei Zhu, MD Baotou Central Hospital

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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01926171     History of Changes
Other Study ID Numbers: BD-IV-49
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases