Clinical trial · Interventional
Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Open Label, Non-randomized, Phase 2 Study Investigating the Effect of RAD001 Monotherapy in Patients With Advanced NSCLC Previously Treated With Either Chemotherapy Only or With Chemotherapy and EGFR Inhibitor(s)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- previously treated with chemotherapy only
- description
- patients previously treated with chemotherapy only (at most 2 prior regimens one of which must have been platinum-based) and no EGFRI
- interventionNames
- Drug: RAD001
- type
- EXPERIMENTAL
- label
- previously treated with chemotherapy + small
- description
- patients previously treated with chemotherapy (at most 2 prior regimens one of which must have been platinum-based) and with one small molecule EGFRI
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- Clinical efficacy based on the evaluation of objective tumor response rate (RR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTWhite DA, Schwartz LH, Dimitrijevic S, Scala LD, Hayes W, Gross SH. Characterization of pneumonitis in patients with advanced non-small cell lung cancer treated with everolimus (RAD001). J Thorac Oncol. 2009 Nov;4(11):1357-63. doi: 10.1097/JTO.0b013e3181ba20b1. PMID 19745764
- RESULTSoria JC, Shepherd FA, Douillard JY, Wolf J, Giaccone G, Crino L, Cappuzzo F, Sharma S, Gross SH, Dimitrijevic S, Di Scala L, Gardner H, Nogova L, Papadimitrakopoulou V. Efficacy of everolimus (RAD001) in patients with advanced NSCLC previously treated with chemotherapy alone or with chemotherapy and EGFR inhibitors. Ann Oncol. 2009 Oct;20(10):1674-81. doi: 10.1093/annonc/mdp060. Epub 2009 Jun 23. PMID 19549709