Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Chidamide
* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry. Aged 18 75 years Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown With at least one measurable lesion White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L Life expectancy >3 months Eastern Cooperative Oncology Group performance status of ≤1 at study entry Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study Have signed informed consent Exclusion Criteria: Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period Organ transplant patients Patients with active bleeding or new thrombotic diseases Patients with body temperature >38.5℃ for more than 3 days Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN Patients with symptomatic brain-metastasis Pregnant or lactating women Patients with mental disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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. | Drug: Chidamide<br>* Given orally<br>* Other names: CS055;Drug: Paclitaxel<br>* Given IV<br>* Other names: TAX;Drug: Carboplatin<br>* Given IV<br>* Other names: Paraplatin;|
| Placebo Comparator: Arm 2<br>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. | Drug: Paclitaxel<br>* Given IV<br>* Other names: TAX;Drug: Carboplatin<br>* Given IV<br>* Other names: Paraplatin;Drug: Placebo<br>* Given orally<br>* Other names: PLB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chidamide,lung cancer