Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

Official Title
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A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy Evidence of measurable disease by radiographic technique Male or Female, 18 years or older ECOG performance status of 0 or 1 Resolution of all acute toxicities of prior therapies Adequate organ function Exclusion Criteria: Major surgery or radiation therapy within 4 weeks Severe hemorrhage within 4 weeks Previous treatment with anti-angiogenesis agents Diagnosis of second malignancy within last five 5 years History of or known brain metastases, spinal cord compression, or carcinomatous meningitis Known HIV Serious acute or chronic illness Current treatment on another clinical trial Pregnant or breastfeeding

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Sunitinib<br>* Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.<br>* Other names: Sutent, SU011248;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall confirmed objective response rate (ORR) |  | From screening until at least 28 days beyond discontinuation of study treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | From screening until disease progression or discontinuation of study | 
| Time to progression (TTP) |  | From screening until disease progression or discontinuation of study | 
| Duration of response (DR) |  | From screening until disease progression or discontinuation of study | 
| Overall survival (OS) |  | From screening until disease progression or discontinuation of study | 
| Probability of survival at 1 year |  | From screening until disease progression or discontinuation of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, carcinoma, sunitinib, Phase 2