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The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred. |
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| Arm 2 | Placebo Comparator | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Given orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is measured from the start of treatment until progression or death,whichever is first met | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 76 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival Rate at 6 Months (6-M-PFS) | 6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month | 6 months |
| Object Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel |
| Drug |
Given IV |
|
|
| Carboplatin | Drug | Given IV |
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| Placebo | Drug | Given orally |
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ORR is defined as percentage of participants with Complete Response and Partial Response,assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)
| Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks |
| Duration of Response (DOR) | DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met | From the first date of response until the date of first documented progression, assessed up to 70 weeks |
| Overall Survival (OS) | OS is measured from the start of treatment until death | From date of randomization until the date of death from any cause, followed for up to 76 weeks |
| Time To Progression (TTP) during the maintenance therapy period | TTP is assessed for patients who complete the 12 weeks of combination therapy. It is measured from the start of maintenance therapy until the criteria of progression is met | From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks |
| Beijing Chest Hospital, Capital Medical University |
| Beijing |
| Beijing Municipality |
| 101149 |
| China |
| Hebei Provincial Tumor Hospital | Shijiazhuang | Hebei | 050011 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| The first Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200030 | China |
| The Second People's Hospital of Sichuan | Chengdu | Sichuan | 82816 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |