Status:
COMPLETED
Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-small-cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of everolimus treatment of patients with advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously treated with chemother...
Eligibility Criteria
Inclusion
- Patients with advanced (unresectable or metastatic) NSCLC
- Tissue sample of the metastatic or primary tumor available for pathology evaluation and molecular marker analyses
- Patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin, and who have documented evidence of tumor progression (Arm 1)
- Patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin as well as a small molecule EGFR inhibitor (as a separate regimen) with documented tumor progression despite at least 4 weeks therapy with either gefitinib or erlotinib (Arm 2)
Exclusion
- Concurrent therapy with agents used otherwise as anticancer therapy (for example, methotrexate for rheumatoid arthritis)
- Any investigational drug, other than EGFR inhibitor (Arm 2), within the preceding 4 weeks
- Chronic treatment with steroids or another immunosuppressive agent
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00124280
Start Date
July 1 2005
Last Update
November 18 2016
Active Locations (2)
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1
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
2
MD Anderson Cancer Center, Department of Thoracic /Head and Neck Medical Oncology
Houston, Texas, United States, 77030