Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib with concurrent radiotherapy | Experimental | Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity. |
|
| Chemoradiotherapy | Active Comparator | Pemetrexed(500mg/m2) + carboplatin (AUC,5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC,5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Icotinib (125 mg ,Three times daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | 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. | two years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Wu, intern | Contact | +86-185-789-52759 | 353992578@qq.com | |
| XiangLi Lai, intern | Contact | +86-138-7719-7891 | 249261276@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| GuoSheng Feng, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| Yuan Liang, MD | Guangxi Department of Public Health | Study Chair |
| Lin Hui, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The people's Hospital of the Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | 530021 | China |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C531470 | icotinib |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pemetrexed | Drug | Pemetrexed(500mg/m2)every 21 days |
|
|
| Carboplatin | Drug | Carboplatin (AUC,5) every 21 days |
|
|
| Thoracic radiotherapy(TRT) | Radiation | TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times) |
|
| Adverse events |
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0. |
| two years |
| Objective response rate | Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. | two years |
| Quality of life | Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire. | two years |
| The People's hospital of Guangxi Zhuang Autonomous |
| Study Chair |
| HeMing Lu, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| ChangJie Huang, MD | Nanning Second People's Hospital | Study Chair |
| GuiSheng LI, MD | Liuzhou Workers' Hospital | Study Chair |
| HaiXin Huang, MD | Liuzhou Workers' Hospital | Study Chair |
| HaoLin Yan, MD | First People's Hospital of Yulin | Study Chair |
| Ping Liang, MD | Guangxi Ruikang Hospital | Study Chair |
| BingQiang Ni, MD | The People's hospital of LiuZhou | Study Chair |
| YanRong Hao, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| XianBin Yuan, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| Shan Gao, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| Xia Wu, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| XiangLi Lai, MD | The People's hospital of Guangxi Zhuang Autonomous | Study Chair |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |