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Completed

NCT Number: NCT01836679

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

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.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Chest Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chidamide

Drug

Given orally

Other names: CS055

paclitaxel

Drug

Given IV

Other names: Taxol, TAX

carboplatin

Drug

Given IV

Other names: CBDCA, Paraplatin

Placebo

Drug

Given orally

Other names: PLB

Primary outcomes

  1. Progression-Free Survival (PFS)

    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

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

Secondary outcomes

  1. Progression-Free Survival Rate at 6 Months (6-M-PFS)

    Time frame: 6 months

    6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month

  2. Object Response Rate (ORR)

    Time frame: 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)

  3. Duration of Response (DOR)

    Time frame: 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

  4. Overall Survival (OS)

    Time frame: 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

  5. Time To Progression (TTP) during the maintenance therapy period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chipscreen Biosciences, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2013
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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