We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Betta Pharmaceuticals Co.,Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707329
First Posted: October 16, 2012
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
  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
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

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 ]

    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 ]
    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 2016
Estimated Primary Completion Date: July 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01707329     History of Changes
Other Study ID Numbers: BD-IC-IV44
First Submitted: October 11, 2012
First Posted: October 16, 2012
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