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This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| icotinib | Experimental | Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| icotinib | Drug | Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 12 months | |
| objective response rate | 2 months | |
| number of patients suffered adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Sun, MD | Cancer Hospital Chinese Academy of Medical Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100021 | China | ||
| Peking Union Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 26599904 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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|
| 15 months |
| Beijing |
| Beijing Municipality |
| 100032 |
| China |
| Bejing Cancer Hospital | Beijing | Beijing Municipality | 100036 | China |
| 307 Hospital of PLA | Beijing | Beijing Municipality | 100071 | China |
| Beijing Chest Hospital | Beijing | Beijing Municipality | 101149 | China |
| Third Affiliated Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Sun yat-sen Univerisity Cancer Center | Guanzhou | Guangdong | 510060 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Hu X, Zhang L, Shi Y, Zhou C, Liu X, Wang D, Song Y, Li Q, Feng J, Qin S, Xv N, Zhou J, Zhang L, Hu C, Zhang S, Luo R, Wang J, Tan F, Wang Y, Ding L, Sun Y. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study. PLoS One. 2015 Nov 24;10(11):e0142500. doi: 10.1371/journal.pone.0142500. eCollection 2015. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |