Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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 chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib,
is based on following:
- The medical need for the better therapy for advanced NSCLC and limited efficacy of the
currently available therapy in advanced NSCLC.
- Postulated association of relevant cell-signaling pathways targeted by everolimus with
different aspects of oncogenesis, disease progression, and response/resistance to
treatment.
- Effectiveness of everolimus and rapamycin in preclinical models of lung cancer
- Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced
NSCLC.
There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus,
may be one of the key changes accounting for different aspects of oncogenesis, disease
progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor
everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes
to logically manipulate the cell's regulatory pathways to enable control of tumor growth.