ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
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ClinicalTrials.gov Identifier: NCT01810367 |
Recruitment Status :
Completed
First Posted : March 13, 2013
Last Update Posted : February 23, 2016
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Sponsor:
Fudan University
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University
Tracking Information | |||
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First Submitted Date ICMJE | March 11, 2013 | ||
First Posted Date ICMJE | March 13, 2013 | ||
Last Update Posted Date | February 23, 2016 | ||
Study Start Date ICMJE | December 2011 | ||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01810367 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC | ||
Official Title ICMJE | 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 ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non Small Cell Lung Cancer | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
84 | ||
Original Estimated Enrollment ICMJE |
250 | ||
Actual Study Completion Date ICMJE | December 2015 | ||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | China | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01810367 | ||
Other Study ID Numbers ICMJE | ABX-CJH | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Chang Jian Hua, Fudan University | ||
Study Sponsor ICMJE | Fudan University | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Fudan University | ||
Verification Date | February 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |