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This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Active Comparator | Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. |
|
| Icotinib+Chemotherapy | Experimental | Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. |
|
| 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. | 6 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Yi Ping, MD | Contact | 0086-13750881678 | zyp@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Yi Ping, M.D. | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Province Tumor Hospital | Active, not recruiting | Changsha | Hunan | 410205 | China | |
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| Icotinib+chemotherapy | Drug | Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. |
|
|
| Sir Run Run Shaw Hospital |
| Active, not recruiting |
| Hangzhou |
| Zhejiang |
| 310000 |
| China |
| The First Affiliated Hospital of Medical School of Zhejiang University | Active, not recruiting | Hangzhou | Zhejiang | 310000 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Active, not recruiting | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| The First Affiliated Hospital of Wenzhou Medical College | Active, not recruiting | Wenzhou | Zhejiang | 325000 | China |
| 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 |
|---|---|
| D004358 | Drug Therapy |
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| C531470 | icotinib |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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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