Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)
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ClinicalTrials.gov Identifier: NCT01040780 |
Recruitment Status :
Completed
First Posted : December 30, 2009
Results First Posted : May 24, 2012
Last Update Posted : February 14, 2014
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer | Drug: Icotinib Drug: Gefitinib | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 399 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Icotinib
125 mg three times daily (375 mg per day) by mouth
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Drug: Icotinib
125 mg three times daily (375 mg per day) by mouth
Other Names:
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Active Comparator: Gefitinib
250 mg every 24 hours by mouth
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Drug: Gefitinib
250 mg every 24 hours by mouth
Other Names:
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- Progression Free Survival [ Time Frame: 2-7 months ]Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
- Overall Survival [ Time Frame: From first study treatment until time of death ]Median number of months from first study treatment until time of death
- Best Tumor Response [ Time Frame: While receiving study treatment; assessed every 21 days until progression ]Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
- Time To Progression [ Time Frame: 2-7 months ]Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.
- Safety and Tolerability [ Time Frame: Assessed over two years ]
Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.
Grade 3 = Severe Grade 4 = Life-threatening or disabling
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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 |
Inclusion Criteria:
- Confirmed NSCLC with Histology or cytology; advanced (IIIb/IV).
- Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.
Exclusion Criteria:
1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
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): NCT01040780
Principal Investigator: | Yan Sun, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | |
Principal Investigator: | Li Zhang, M.D. | Sun Yat-sen University | |
Study Director: | Fenlai Tan, M.D./Ph.D. | Zhejiang Betapharma Inc. |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Betta Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01040780 |
Other Study ID Numbers: |
BPI-2009 |
First Posted: | December 30, 2009 Key Record Dates |
Results First Posted: | May 24, 2012 |
Last Update Posted: | February 14, 2014 |
Last Verified: | January 2014 |
Efficacy Safety EGFR-TKI phase III NSCLC |
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 Gefitinib Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |