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The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.
Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | 125 mg three times daily (375 mg per day) by mouth |
|
| Gefitinib | Active Comparator | 250 mg every 24 hours by mouth |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | 125 mg three times daily (375 mg per day) by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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. | 2-7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death |
| Best Tumor Response | 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
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| Name | Affiliation | Role |
|---|---|---|
| Yan Sun, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Li Zhang, M.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Fenlai Tan, M.D./Ph.D. | Zhejiang Betapharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | 100020 | China | ||
| Cancer Hospital, Chinese Academy of Medical Science |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23948350 | Background | Camidge DR. Icotinib: kick-starting the Chinese anticancer drug industry. Lancet Oncol. 2013 Sep;14(10):913-4. doi: 10.1016/S1470-2045(13)70385-1. Epub 2013 Aug 13. No abstract available. | |
| 21144613 | Background | Zhao Q, Shentu J, Xu N, Zhou J, Yang G, Yao Y, Tan F, Liu D, Wang Y, Zhou J. Phase I study of icotinib hydrochloride (BPI-2009H), an oral EGFR tyrosine kinase inhibitor, in patients with advanced NSCLC and other solid tumors. Lung Cancer. 2011 Aug;73(2):195-202. doi: 10.1016/j.lungcan.2010.11.007. Epub 2010 Dec 8. |
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Patients were enrolled between 26 Febrary 2009 and 13 November 2010 across 27 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Icotinib | Icotinib 125 mg three times daily (375 mg per day) by mouth |
| FG001 | Gefitinib | Gefitinib 250 mg every 24 hours by mouth |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Gefitinib | Drug | 250 mg every 24 hours by mouth |
|
|
| While receiving study treatment; assessed every 21 days until progression |
| Time To Progression | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression. | 2-7 months |
| Safety and Tolerability | 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 | Assessed over two years |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
| Bejing Cancer Hospital | Beijing | Beijing Municipality | 100036 | China |
| 307 Hospital of PLA | Beijing | Beijing Municipality | 100071 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100079 | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Beijing Chest Hospital | Beijing | Beijing Municipality | 101149 | China |
| Third Affiliated Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Guanghzou General Hospital of PLA | Guangzhou | Guangdong | 510000 | China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| Nanfang Hospital， Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Sun yat-sen Univerisity Cancer Center | Guanzhou | Guangdong | 510060 | China |
| the Second Xiangya Hospital，Central South University | Changsha | Hunan | 410011 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| 81 Hospital of PLA | Nanjing | Jiangsu | 210002 | China |
| Nanjing General Hospital of Nanjing Command，PLA | Nanjing | Jiangsu | 210002 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| Ruijin Hospital，Shanghai Jiao-Tong University | Shanghai | Shanghai Municipality | 200023 | China |
| Zhongshan Hospital，Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Changhai Hospital， Second Military Medical University | Shanghai | Shanghai Municipality | 200433 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Tangdu Hospital, Fourth Military Medical University | Xi’an | Shanxi | 710000 | China |
| Xijing Hospital, Fourth Military Medical University | Xi’an | Shanxi | 710032 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310022 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| 23948351 | Result | Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13. |
| 22112293 | Derived | Tan F, Shen X, Wang D, Xie G, Zhang X, Ding L, Hu Y, He W, Wang Y, Wang Y. Icotinib (BPI-2009H), a novel EGFR tyrosine kinase inhibitor, displays potent efficacy in preclinical studies. Lung Cancer. 2012 May;76(2):177-82. doi: 10.1016/j.lungcan.2011.10.023. Epub 2011 Nov 22. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Icotinib | Icotinib 125 mg three times daily (375 mg per day) by mouth |
| BG001 | Gefitinib | Gefitinib 250 mg every 24 hours by mouth |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | 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. | All patients who received at least one dose of study drug with measurable disease at baseline. | Posted | Median | 95% Confidence Interval | months | 2-7 months |
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| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Median number of months from first study treatment until time of death | Posted | Median | 95% Confidence Interval | months | From first study treatment until time of death |
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| ||||||||||||||||||||||||||||||
| Secondary | Best Tumor Response | 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 | Posted | Number | percentage of patients | While receiving study treatment; assessed every 21 days until progression |
|
| |||||||||||||||||||||||||||||||
| Secondary | Time To Progression | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression. | Posted | Median | 95% Confidence Interval | months | 2-7 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability | 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 | Posted | Number | participants | Assessed over two years |
|
|
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Events were collected by systematic assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Icotinib | Icotinib 125 mg three times daily (375 mg per day) by mouth | 13 | 200 | 166 | 200 | ||
| EG001 | Gefitinib | Gefitinib 250 mg every 24 hours by mouth | 15 | 199 | 165 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
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| Haemorrhage | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Cardio-respiratory failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Multi-organ failure | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Hospitalization due to progression | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Aminotransferase Increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pyrexia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hepatic Function Abnormal | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis of oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yan Sun, M.D. | Cancer Hospital, Chinese Academy of Medical Sciences | 0086-010-87788519 | zhangheping@csco.org.cn |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C531470 | icotinib |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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