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

Chipscreen Biosciences

Status and phase: Completed; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: Chidamide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01836679

CDM204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

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.

Treatment:

Drug: Chidamide

Drug: Carboplatin

Drug: Paclitaxel

Arm 2

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Carboplatin

Drug: Paclitaxel