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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

Phase 2
18 Years
75 Years
Open (Enrolling)
Non-small-cell Lung Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

PFS is measured from the start of treatment until progression or death,whichever is first met

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Yuankai Shi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

October 2014

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Chidamide,lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms