ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810367
• Other study ID #: ABX-CJH
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2013
• Last updated: February 22, 2016
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

1.18~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values:

• leucocyte = 4×109/L

• neutrophil = 1.5×109/L

• platelet = 100×109/L

• Hemoglobin = 10g/L

• ALT and

• AST = 2.5×ULN (= 5×ULN if liver metastasis) 7.Signed written informed consent

Exclusion Criteria:

• Patients have used drugs according to protocol

• Patients were allergic to pemetrexed or cisplatin

• Patients received radiotherapy or other biological treatment 4 weeks before the trial

• Uncontrolled hydrothorax or hydropericardium

• neuropathy toxicity = CTC 3

• Severe symptomatic heart disease

• Active upper gastrointestinal ulcer or digestive disfunction

• Severe infection or metabolic disfunction

• Patients with other malignant tumor

• Uncontrolled brain metastases

• Patients have accepted other clinical trials

• Female patients during their pregnant and lactation period, or patients without contraception

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• ABX Combined With Cisplatin

• Gemcitabine Combined With Cisplatin

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		from the first cycle of treatment (day one) to two month after the last cycle	No