A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

Study Overview
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Brief Summary
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This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.

Official Title
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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

Conditions
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Carcinoma, Non-Small Cell Lung

Intervention / Treatment
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* Drug: erlotinib
* Drug: sunitinib
* Drug: erlotinib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with locally advanced/metastatic non-small cell lung cancer Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen Exclusion Criteria: Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors History of or known brain metastases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: erlotinib<br>* plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity<br>Drug: sunitinib<br>* Sunitinib 37.5 mg daily by oral capsules in a continuous regimen<br>|
| Active Comparator: 2<br> | Drug: erlotinib<br>* plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity<br>Drug: placebo<br>* Placebo daily by oral capsules in a continuous regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | 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. | Baseline to death or 28 days after last dose for the last participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | 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). | Baseline to disease progression or death due to any cause or 28 days after last dose | 
| Percentage of Participants With Objective Response (OR) | 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. | Baseline to disease progression or discontinuation from study or 28 days after last dose | 
| Duration of Response (DR) | 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. | Baseline to disease progression or death or discontinuation from study or 28 days after last dose | 
| One-year Survival Probability | 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. | Baseline until death or until 28 days after last dose for the last participant | 
| EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score | 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. | Baseline and End of Treatment (EOT) or Withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, sunitinib, erlotinib, Phase 3