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Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03754530
Collaborator
(none)
162
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with 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. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD

Drug: Icotinib
orally three times per day
Other Names:
  • WBRT or SRS

    		•
    Experimental: Icotinib plus radiation therapy

    Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.

    Drug: Icotinib
    orally three times per day
    Other Names:
  • WBRT or SRS

    • Radiation: WBRT or SRS
    >3 with WBRT;<=3 with SRS
    Other Names:
  • Icotinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival of intracranial lesions [10 months]

      Number of participants with progress of intracranial lesions

    Secondary Outcome Measures

    1. Progression-free survival [8 months]

      Number of participants with progress of any places in body

    2. Objective response rate of intracranial lesions [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases

    • Histological or cytological confirmation of EGRF positive sensitive mutation

    • Diagnosis of brain metastases on a Gadolinium-enhanced MRI

    Exclusion Criteria:

    • Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux

    • Previous usage of radiation with brain

    • CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Study Director: Li jiancheng, Fujian oncology hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03754530
    Other Study ID Numbers:
    • 2018-007-02
    First Posted:
    Nov 27, 2018
    Last Update Posted:
    Nov 27, 2018
    Last Verified:
    Nov 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Betta Pharmaceuticals Co., Ltd.
    NSCLC brain metastases
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Neoplasms, Second Primary
    Brain Neoplasms

    Study Results

    No Results Posted as of Nov 27, 2018