ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
Phase 2
Completed
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Drug: ABX Combined With Cisplatin
- Registration Number
- NCT01810367
- Lead Sponsor
- Fudan University
- Brief Summary
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
Not provided
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABX Combined With Cisplatin ABX Combined With Cisplatin ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt Gemcitabine Combined With Cisplatin Gemcitabine Combined With Cisplatin gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.
- Primary Outcome Measures
Name Time Method PFS from the first cycle of treatment (day one) to two month after the last cycle
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cancer hospital Fudan University
🇨🇳Shanghai, Shanghai, China