Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Novartis Pharmaceuticals85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Clinical efficacy based on the evaluation of objective tumor response rate (RR)

Time frame: until progressive disease or unacceptable toxicity.

Secondary Outcomes

To assess safety of RAD001 monotherapy

Time frame: as long as patients are in the study

To assess additional clinical efficacy of RAD001

Time frame: as long as patients are in the study

To assess the steady state levels of RAD001 in blood

Time frame: as long as patients are in the study

To investigate potential molecular markers predictive of clinical effect

Time frame: as long as patients are in the study

Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes