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INCREASE: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02404675
Collaborator
(none)
240
Enrollment
1
Location
3
Arms
41
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 21 icotinib (250mg)

Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.

Drug: icotinib
Other Names:
  • conmana

    		•
    Active Comparator: 21 icotinib (125mg)

    Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity

    Drug: icotinib
    Other Names:
  • conmana

    		•
    Experimental: 19 icotinib (125mg)

    Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity

    Drug: icotinib
    Other Names:
  • conmana

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [12 months]

    Secondary Outcome Measures

    1. Overall survival [20 months]

    2. Objective response rates [12 weeks]

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)

    • Positive EGFR 21 exon mutation or 19 exon deletion

    • Age 18-75 years old with performance status of 0 to 2

    • With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria

    • Adequate hematological, biochemical and organ functions.

    Exclusion Criteria:

    • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

    • Evidence of interstitial lung diseases

    • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Chest Hospital, Capital Medical University Beijing China

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02404675
    Other Study ID Numbers:
    • AKTN-NSCLC-01
    First Posted:
    Mar 31, 2015
    Last Update Posted:
    Jul 28, 2017
    Last Verified:
    Jul 1, 2017
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 28, 2017