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

• ClinicalTrials.gov Identifier: NCT01810367
• Recruitment Status: Completed
• First Posted: March 13, 2013
• Last Update Posted: February 23, 2016
• Sponsor: Fudan University
• Information provided by (Responsible Party): Chang Jian Hua, Fudan University

Tracking Information

• First Submitted Date: March 11, 2013
• First Posted Date: March 13, 2013
• Last Update Posted Date: February 23, 2016
• Study Start Date: December 2011
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 12, 2013): PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01810367 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non Small Cell Lung Cancer

Intervention

• Drug: ABX Combined With Cisplatin
• Drug: Gemcitabine Combined With Cisplatin

Study Arms

• Experimental: ABX Combined With Cisplatin
  ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt
  Intervention: Drug: ABX Combined With Cisplatin
• Active Comparator: Gemcitabine Combined With Cisplatin
  gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.
  Intervention: Drug: Gemcitabine Combined With Cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2016): 84
• Original Estimated Enrollment (submitted: March 12, 2013): 250
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01810367
• Other Study ID Numbers: ABX-CJH
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chang Jian Hua, Fudan University
• Study Sponsor: Fudan University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fudan University
• Verification Date: February 2016