Non-small-cell Lung Cancer
Conditions
Keywords
Chidamide,lung cancer
Brief summary
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
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.
Interventions
DRUGChidamide
Given orally
DRUGPaclitaxel
Given IV
DRUGCarboplatin
Given IV
DRUGPlacebo
Given orally
Sponsors
Chipscreen Biosciences, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 | PFS is measured from the start of treatment until progression or death,whichever is first met |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival Rate at 6 Months (6-M-PFS) | 6 months | 6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month |
| Object Response Rate (ORR) | 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 | 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) |
| Duration of Response (DOR) | From the first date of response until the date of first documented progression, assessed up to 70 weeks | DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met |
| Overall Survival (OS) | From date of randomization until the date of death from any cause, followed for up to 76 weeks | OS is measured from the start of treatment until death |
| Time To Progression (TTP) during the maintenance therapy period | From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks | 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 |
Countries
China
Outcome results
None listed