Phase Ib Clinical Trial of Chidamide Combined With Paclitaxel and Carboplatin Chemotherapy in Patients with Advanced Non–Small-Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-12002283

Enrollment

Unknown

Registered

2012-06-18

Start date

2011-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non Small Cell Lung Cancer (NSCLC)

Interventions

Total:Paclitaxel 175mg/m2 and Carboplatin AUC=5mg/ml·min once every 3 weeks Chidamide TIW escalated from 20mg

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have signed the Informed Consent Form; 2. Aged 18 years and elder; 3. With cytologic or histologic confirmation of NSCLC, stage IIIb or IV, first diagnosed or had no prior systematic drug treatment after surgery; 4. With at least one measurable lesion; 5. White blood cell counts >=4*10^9/L; Platelet counts >=100*10^9/L and Hemoglobin >=11g/L; 6. Life expectancy >=3 months; 7. ECOG performance status 0 or 1; 8. HCG blood test negative for reproductive age women in screening, and agree to carry out birth control during the trial; 9. Weight: male 67+/-20 kg (47-87kg), female 55+/-20kg (35-75kg); 10. Good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients who have participated another clinical trial during the 30 days before enrollment or are in another new drug clinical trial; 2. Patients with history of clinically significant QTc prolongation (>450ms), or ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), clinically significant coronary artery disease which needs drug treatment; 3. Male patients who have fertility desires; 4. Patients who have undergone organ transplantation; 5. Patients with active bleeding or newly diagnosed thromboembolic disease; 6. Patients with active ulcer or bleeding in gastrointestinal tract; 7. Patients with active infections; 8. Hepatic function: Serum total bilirubin >1.5*normal range; ALT/AST >2.5*normal range or 5*normal range for liver metastasis; Renal function: Serum creatine >1.5*normal range; 9. Patients with symptomatic brain metastases; 10. Patients with mental disorders; 11. Patients considered by investigators not suitable for the study.

Design outcomes

Primary

Measure	Time frame
MT;	—

Secondary

Measure	Time frame
Pharmacokinetic parameters;preliminary efficacy;	—

Countries

China

Contacts

Public ContactYuankai Shi

syuankai@yahoo.cn+86 10 87788268

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026