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Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01843647
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
58.1
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation
Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.

Drug: Icotinib
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
Other Names:
  • Commana
  • BPI-2009

    		•
    Active Comparator: Chemotherapy

    Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.

    Drug: Chemotherapy
    After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.
    Other Names:
  • Vinorelbine
  • Cisplatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [8 weeks]

    2. Disease free survival [1 year]

    Secondary Outcome Measures

    1. The pathological complete response rate after neoadjuvant therapy with icotinib [8 weeks]

    2. The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib [8 weeks]

    3. The resection rate of patients after neoadjuvant therapy with icotinib [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.

    3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.

    4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.

    Exclusion Criteria:
      1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug.
    1. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhejiang cancer hospital Hangzhou Zhejiang China 310022

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Weimin Mao, MD, Zhejiang Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01843647
    Other Study ID Numbers:
    • BD-IC-IV06
    First Posted:
    Apr 30, 2013
    Last Update Posted:
    Jul 15, 2015
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Cisplatin
    Vinorelbine

    Study Results

    No Results Posted as of Jul 15, 2015