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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.

NCT05068427

Non Small Cell Lung Cancer

COMPLETED PHASE2

Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer

NCT05309629

Extensive-stage Small-cell Lung Cancer

COMPLETED PHASE2

Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00040794

Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer +4 more

COMPLETED PHASE2

The Efficacy and Safety of the Combination of PD-1 With Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients

NCT07138755

NSCLC Sintilimab Adaptive Radiotherapy

NOT_YET_RECRUITING PHASE2

Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer

NCT04830813

Small Cell Lung Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small-cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

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.

Group Type EXPERIMENTAL

Chidamide

Intervention Type DRUG

Given orally

Paclitaxel

Intervention Type DRUG

Given IV

Carboplatin

Intervention Type DRUG

Given IV

Arm 2

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.

Group Type PLACEBO_COMPARATOR

Paclitaxel

Intervention Type DRUG

Given IV

Carboplatin

Intervention Type DRUG

Given IV

Placebo

Intervention Type DRUG

Given orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chidamide

Given orally

Intervention Type DRUG

Paclitaxel

Given IV

Intervention Type DRUG

Carboplatin

Given IV

Intervention Type DRUG

Placebo

Given orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CS055 Taxol TAX CBDCA Paraplatin PLB

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No