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This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential icotinib plus chemotherapy | Experimental | Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. |
|
| Icotinib | Active Comparator | Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential Icotinib Plus Chemotherapy | Drug | Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. |
| 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. | 15 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helong Zhang, MD | Contact | 13709202616 |
| Name | Affiliation | Role |
|---|---|---|
| Helong Zhang, MD | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Lanzhou University | Active, not recruiting | Lanzhou | Gansu | 730000 | China | |
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|
|
| Icotinib | Drug | Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity. |
|
|
| Objective response rate |
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| 15 months |
| Adverse events | The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0. | 24 months |
| Lanzhou military region general hospital |
| Active, not recruiting |
| Lanzhou |
| Gansu |
| 730050 |
| China |
| General Hospital of Guangzhou Military Command | Active, not recruiting | Guangzhou | Guangdong | 510010 | China |
| Cancer Hospital of Sun Yat-sen | Active, not recruiting | Guangzhou | Guangdong | 510060 | China |
| First Affiliated Hospital of Guangzhou Medical College | Active, not recruiting | Guangzhou | Guangdong | 510120 | China |
| Jiangmen central hospital | Active, not recruiting | Jiangmen | Guangdong | 529030 | China |
| The university of Hong Kong-Shenzhen Hospital | Active, not recruiting | Shenzhen | Guangdong | 518000 | China |
| Shenzhen People's Hospital | Active, not recruiting | Shenzhen | Guangdong | 518020 | China |
| Medical Oncology,Shenzhen Second People's Hospital | Active, not recruiting | Shenzhen | Guangdong | 518035 | China |
| Thoracic Surgery,Shenzhen Second People's Hospital | Active, not recruiting | Shenzhen | Guangdong | 518035 | China |
| Peking University Shenzhen Hospital | Active, not recruiting | Shenzhen | Guangdong | 518036 | China |
| Guangdong Agribusiness Center Hospital | Active, not recruiting | Zhanjiang | Guangdong | 524009 | China |
| First Affiliated Hospital of Guangxi Medical University | Active, not recruiting | Nanning | Guangxi | 530021 | China |
| Hainan Provincal Nong Ken Hospital | Active, not recruiting | Haikou | Hainan | 570311 | China |
| Hainan Provincial People's Hospital | Active, not recruiting | Haikou | Hainan | 570311 | China |
| First Affiliated Hospital of Zhengzhou University | Active, not recruiting | Zhengzhou | Henan | 450052 | China |
| Medical Oncology,General Hospital of Ningxia Medical University | Active, not recruiting | Yinchuan | Ningxia | 750004 | China |
| Radiation Oncology,General Hospital of Ningxia Medical University | Active, not recruiting | Yinchuan | Ningxia | 750004 | China |
| Respiratory medicine,General Hospital of Ningxia Medical University | Active, not recruiting | Yinchuan | Ningxia | 750004 | China |
| Baoji Central Hospital | Active, not recruiting | Baoji | Shanxi | 721008 | China |
| 3201 Hospital, Hanzhong, Shanxi | Active, not recruiting | Hanzhong | Shanxi | 723000 | China |
| Shaanxi province people's hospital | Active, not recruiting | Xi’an | Shanxi | 710000 | China |
| Second Affiliated Hospital of Xi'an Jiaotong University | Active, not recruiting | Xi’an | Shanxi | 710004 | China |
| Xi'an Chang'an Hospital | Active, not recruiting | Xi’an | Shanxi | 710018 | China |
| Tangdu Hospital,Fourth Military Medical University | Recruiting | Xi’an | Shanxi | 710038 | China |
|
| First Affiliated Hospital of Xi'an Jiaotong University | Active, not recruiting | Xi’an | Shanxi | 710061 | China |
| Shanxi Cancer Hospital | Active, not recruiting | Xi’an | Shanxi | 710061 | China |
| Urumqi General Hospital of Lanzhou Military Region General Hospital | Active, not recruiting | Ürümqi | Xinjiang | 830000 | China |
| Xinjiang medical university affiliated tumor hospital | Active, not recruiting | Ürümqi | Xinjiang | 830000 | China |
| First Affiliated Hospital of Xinjiang Medical University | Active, not recruiting | Ürümqi | Xinjiang | 830054 | China |
| Autonome Region Xinjiang Uygur Chinese medicine hospital | Active, not recruiting | Ürümqi | Xinjiang | 830099 | China |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000068437 | Pemetrexed |
| C531470 | icotinib |
| 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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