Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Tracking Information
First Submitted Date ICMJE	August 4, 2010
First Posted Date ICMJE	September 1, 2010
Last Update Posted Date	September 3, 2010
Study Start Date ICMJE	December 2009
Estimated Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 31, 2010)	response rate [ Time Frame: six weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01192243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 2, 2010)	Number of Participants with Adverse Events [ Time Frame: six weeks ]according to NCI CTC V3.0; Progression free survival [ Time Frame: six weeks ]; quality of life [ Time Frame: six weeks ]according to FACT-LCS scores
Original Secondary Outcome Measures ICMJE; (submitted: August 31, 2010)	adverse event [ Time Frame: six weeks ]according to NCI CTC V3.0; Progression free survival [ Time Frame: six weeks ]according to NCI CTC V3.0; quality of life [ Time Frame: six weeks ]according to FACT-LCS scores
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Official Title ICMJE	Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
Brief Summary	The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Toxicity; Non-small Cell Lung Cancer
Intervention ICMJE	Drug: Gefitinib 250mg qd po d3-16; Drug: Pemetrexed 500mg/m2 venous infusion,D1,q3w; Drug: Cisplatin or carboplatin Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 31, 2010)	68
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer; Age from 18 to 70 years old; At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools; ECOG 0-1; Expected life time longer than 12 weeks; 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) Exclusion Criteria: Patients have not 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 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	NCT01192243
Other Study ID Numbers ICMJE	Iressa combined with Pem/Cis
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
Study Sponsor ICMJE	Fudan University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
PRS Account	Fudan University
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP