A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
|ClinicalTrials.gov Identifier: NCT00457392|
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : August 2, 2011
Last Update Posted : October 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small Cell Lung||Drug: erlotinib Drug: sunitinib Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||960 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib|
|Study Start Date :||July 2007|
|Primary Completion Date :||July 2010|
|Study Completion Date :||December 2012|
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicityDrug: sunitinib
Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
|Active Comparator: 2||
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicityDrug: placebo
Placebo daily by oral capsules in a continuous regimen
- Overall Survival (OS) [ Time Frame: Baseline to death or 28 days after last dose for the last participant ]Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.
- Progression-Free Survival (PFS) [ Time Frame: Baseline to disease progression or death due to any cause or 28 days after last dose ]Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
- Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline to disease progression or discontinuation from study or 28 days after last dose ]Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
- Duration of Response (DR) [ Time Frame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose ]Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.
- One-year Survival Probability [ Time Frame: Baseline until death or until 28 days after last dose for the last participant ]The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate.
- EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline and End of Treatment (EOT) or Withdrawal ]EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457392
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|