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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Betta Pharmaceuticals Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01707329
First received: October 11, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: Chemotherapy
Drug: Icotinib+chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 180
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01707329     History of Changes
Other Study ID Numbers: BD-IC-IV44
Study First Received: October 11, 2012
Last Updated: June 26, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014