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Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment

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ClinicalTrials.gov Identifier: NCT01707329
Recruitment Status : Unknown
Verified September 2015 by Betta Pharmaceuticals Co.,Ltd..
Recruitment status was:  Recruiting
First Posted : October 16, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.

Study Description
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Brief Summary:
This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Chemotherapy Drug: Icotinib+chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC
Study Start Date : September 2012
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Chemotherapy
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
 Drug: Chemotherapy
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Other Names:
  • Taxotere
  • ALIMTA
Experimental: Icotinib+Chemotherapy
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
 Drug: Icotinib+chemotherapy
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Other Names:
  • Icotinib
  • Comana
  • BPI-2009


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 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 [ Time Frame: 12 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.


Eligibility Criteria
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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:

  • Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
  • No previous targeted treatment such as gefitinib, erlotinib.
  • With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
  • WHO performance status(PS)<= 2
  • N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
  • Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

  • Allergic to icotinib
  • Patients with metastatic brain tumors with symptoms.
  • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Contacts and Locations
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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): NCT01707329


Contacts
Contact: Zhang Yi Ping, MD 0086-13750881678 zyp@medmail.com.cn

Locations
China, Hunan
Hunan Province Tumor Hospital Active, not recruiting
Changsha, Hunan, China, 410205
China, Zhejiang
Sir Run Run Shaw Hospital Active, not recruiting
Hangzhou, Zhejiang, China, 310000
The First Affiliated Hospital of Medical School of Zhejiang University Active, not recruiting
Hangzhou, Zhejiang, China, 310000
The Second Affiliated Hospital of Zhejiang University School of Medicine Active, not recruiting
Hangzhou, Zhejiang, China, 310000
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zhang Yi Ping, M.D.    0086-13750881678    zyp@medmail.com.cn   
Principal Investigator: Zhang Yi Ping, M.D.         
The First Affiliated Hospital of Wenzhou Medical College Active, not recruiting
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Zhang Yi Ping, M.D. Zhejiang Cancer Hospital
More Information
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Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01707329     History of Changes
Other Study ID Numbers: BD-IC-IV44
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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
 Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors