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The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.
This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Icotinib 125mg is administered orally three times per day. |
|
| Chemotherapy | Active Comparator | Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Icotinib: 125 mg is administered orally three times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 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. | 20 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shi Yuankai, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical Univercity | Hefei | Anhui | 230022 | China | ||
| Chinese People's Liberation Army (PLA) General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28945850 | Result | Shi YK, Wang L, Han BH, Li W, Yu P, Liu YP, Ding CM, Song X, Ma ZY, Ren XL, Feng JF, Zhang HL, Chen GY, Han XH, Wu N, Yao C, Song Y, Zhang SC, Song W, Liu XQ, Zhao SJ, Lin YC, Ye XQ, Li K, Shu YQ, Ding LM, Tan FL, Sun Y. First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017 Oct 1;28(10):2443-2450. doi: 10.1093/annonc/mdx359. |
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| Chemotherapy | Drug | First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed. |
|
|
| Objective response rate |
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response. |
| 12 weeks |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
| Beijing Hospital for Chest Tumors & Tuberculosis Diseases | Beijing | Beijing Municipality | 101149 | China |
| Xinqiao Hospital, The Third Military Medical University | Chongqing | Chongqing Municipality | 400037 | China |
| The First Affiliated Hospital Of Guangzhou Medical Collage | Guangzhou | Guangdong | 510120 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Hebei Provincal Tumor Hospital | Shijiazhuang | Hebei | 050011 | China |
| Harbin Medical Univercity Cancer Hospital | Harbin | Heilongjiang | 110001 | China |
| Henan Provincal Tumor Hospital | Zhengzhou | Henan | 450003 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| Jiangsu Provincal Tumor Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Bethune Hospital of Jilin Univercity | Changchun | Jilin | 130021 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity | Shanghai | Shanghai Municipality | 200030 | China |
| Zhongshan Hospital Affiliated to Fudan Univercity | Shanghai | Shanghai Municipality | 200032 | China |
| Changhai Hospital, The Second Military Medical University | Shanghai | Shanghai Municipality | 200433 | China |
| Xijing Hospital | Xian | Shanxi | 710032 | China |
| Sichuan Provincal Tumor Hospital | Chengdu | Sichuan | 610041 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| ID | Term |
|---|---|
| C531470 | icotinib |
| D004358 | Drug Therapy |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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