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This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.
Primary endpoint:
Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib
Secondary endpoint:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Icotinib | Experimental | Icotinib: 125mg, oral administration, three times per day. |
|
| Chemotherapy Regimen 1 | Active Comparator | Chemotherapy Regimen 1:Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. |
|
| Chemotherapy Regimen 2 | Active Comparator | Chemotherapy Regimen 2:Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Drug | Icotinib: 125mg, oral administration, three times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive. | 24 months |
| Time to Tumor Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiao Shunchang, MD | Contact | 0086-13801380677 |
| Name | Affiliation | Role |
|---|---|---|
| Jiao Shunchang, MD | Chinese People's Liberation Army (PLA) General Hospital | Principal Investigator |
| Fang Jian, MD | Peking University Cancer Hospital & Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese People's Liberation Army (PLA) General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| 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 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| Chemotherapy | Drug | Chemotherapy Regimen 1:Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. |
|
|
| Chemotherapy | Drug | Chemotherapy Regimen 2:Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. |
|
|
TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
| 8 months |
| Objective response rate | Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1. | 3 months |
| Number of participants with adverse events | Adverse events assessed by CTCAE4.0. | 24 months |
| Bai Chunmei, MD |
| Peking Union Medical College Hospital |
| Study Director |
| Liu Wei, MD | Hebei Provincal Tumor Hospital | Study Director |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |