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Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02103257
Collaborator
(none)
192
Enrollment
31
Locations
2
Arms
42.1
Duration (Months)
6.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Mar 1, 2016
Anticipated Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequential icotinib plus chemotherapy

Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.

Drug: Sequential Icotinib Plus Chemotherapy
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Other Names:
  • ALIMTA
  • DDP
  • Comana, BPI-2009

    		•
    Active Comparator: Icotinib

    Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.

    Drug: Icotinib
    Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
    Other Names:
  • Comana
  • BPI-2009

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [15 months]

      A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

    Secondary Outcome Measures

    1. Overall survival [24 months]

      Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

    2. Objective response rate [15 months]

      Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    3. Adverse events [24 months]

      The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.

    Eligibility Criteria

    Criteria

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

    • Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)

    • Patients must have previously untreated locally advanced or metastatic NSCLC

    • EGFR activating mutation (exon 19 deletion, L858R) is required

    • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

    Exclusion Criteria:

    • Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR

    • Patients with wild-type EGFR

    • Any other investigational agents are not permitted

    • Any evidence of interstitial lung disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Hospital of Lanzhou University Lanzhou Gansu China 730000
    2 Lanzhou military region general hospital Lanzhou Gansu China 730050
    3 General Hospital of Guangzhou Military Command Guangzhou Guangdong China 510010
    4 Cancer Hospital of Sun Yat-sen Guangzhou Guangdong China 510060
    5 First Affiliated Hospital of Guangzhou Medical College Guangzhou Guangdong China 510120
    6 Jiangmen central hospital Jiangmen Guangdong China 529030
    7 The university of Hong Kong-Shenzhen Hospital Shenzhen Guangdong China 518000
    8 Shenzhen People's Hospital Shenzhen Guangdong China 518020
    9 Medical Oncology,Shenzhen Second People's Hospital Shenzhen Guangdong China 518035
    10 Thoracic Surgery,Shenzhen Second People's Hospital Shenzhen Guangdong China 518035
    11 Peking University Shenzhen Hospital Shenzhen Guangdong China 518036
    12 Guangdong Agribusiness Center Hospital Zhanjiang Guangdong China 524009
    13 First Affiliated Hospital of Guangxi Medical University Nanning Guangxi China 530021
    14 Hainan Provincal Nong Ken Hospital Haikou Hainan China 570311
    15 Hainan Provincial People's Hospital Haikou Hainan China 570311
    16 First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
    17 Medical Oncology，General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004
    18 Radiation Oncology，General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004
    19 Respiratory medicine，General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004
    20 Baoji Central Hospital Baoji Shanxi China 721008
    21 3201 Hospital, Hanzhong, Shanxi Hanzhong Shanxi China 723000
    22 Shaanxi province people's hospital Xi'an Shanxi China 710000
    23 Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China 710004
    24 Xi'an Chang'an Hospital Xi'an Shanxi China 710018
    25 Tangdu Hospital，Fourth Military Medical University Xi'an Shanxi China 710038
    26 First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China 710061
    27 Shanxi Cancer Hospital Xi'an Shanxi China 710061
    28 Urumqi General Hospital of Lanzhou Military Region General Hospital Urumqi Xinjiang China 830000
    29 Xinjiang medical university affiliated tumor hospital Urumqi Xinjiang China 830000
    30 First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang China 830054
    31 Autonome Region Xinjiang Uygur Chinese medicine hospital Urumqi Xinjiang China 830099

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Helong Zhang, MD, Tang-Du Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02103257
    Other Study ID Numbers:
    • BD-IC-IV62
    First Posted:
    Apr 3, 2014
    Last Update Posted:
    Apr 29, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung

    Study Results

    No Results Posted as of Apr 29, 2015