Clinical trial NCT01836679: Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
Official title: A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Keywords: Chidamide,lung cancer
Lead sponsor: Chipscreen Biosciences, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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 outcomes:
measure: Progression-Free Survival Rate at 6 Months (6-M-PFS)
timeFrame: 6 months
measure: Object Response Rate (ORR)
timeFrame: 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
measure: Duration of Response (DOR)
timeFrame: From the first date of response until the date of first documented progression, assessed up to 70 weeks
measure: Overall Survival (OS)
timeFrame: From date of randomization until the date of death from any cause, followed for up to 76 weeks
measure: Time To Progression (TTP) during the maintenance therapy period
timeFrame: From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
city: Shijiazhuang
country: China
facility: Hebei Provincial Tumor Hospital
state: Hebei
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The first Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
state: Shanghai
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi
role: PRINCIPAL_INVESTIGATOR
References: