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High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

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ClinicalTrials.gov Identifier: NCT02027090
Recruitment Status : Unknown
Verified May 2015 by Betta Pharmaceuticals Co.,Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 3, 2014
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.

Brief Summary:
We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Routine dose icotinib Drug: Higher dose icotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study
Study Start Date : January 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Higher dose icotinib
Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.
Drug: Higher dose icotinib
After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.
Other Name: Commana

Active Comparator: Routine dose icotinib
Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.
Drug: Routine dose icotinib
Icotinib is administered 125 mg three times daily.
Other Name: Commana




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 18 months ]
  2. Response rate assessed using the RECIST criteria [ Time Frame: 2 months ]
  3. The number of patients who suffered adverse events [ Time Frame: 30 months ]
    Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0



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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);
  • Pretreated with at least 1 platinum-based chemotherapy;
  • 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;
  • Adequate organ functions;
  • 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.

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): NCT02027090


Locations
China, Shanghai
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Shun Lu, MD Shanghai Chest Hospital

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT02027090     History of Changes
Other Study ID Numbers: BD-IC-IV17
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

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