A study to test an oral combination of letrozole and everolimus for patients with advanced lung cancer who have progressed on first line chemotherapy.

Phase 2

Recruiting

• Conditions: Non Small Cell lung cancer; on Small Cell lung cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12607000218493
• Lead Sponsor: Dept of Medical Oncology, Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of non-small cell lung cancer of either gender. 2. Age > 18 years for males. Females should be post-menopausal, which is defined as:• Prior oopherectomy, or • 12 month-history of amenorrhoea, or • FSH (Follicle Stimulating Hormone) and LH (Luteinizing Hormone) in post-menopausal range. There is no upper age limit. 3. performance status = 2.4. Adequate organ function• Hematological- Hb> 90 g/L, Absolute Neutrophil Count = 1.5 x 109/L, platelets = 100 x 109/L.• Liver functions- bilirubin = 2 x upper limit normal (ULN), Aspartate Aminotransferase /Alanine Aminotransferase/ Alkaline Phosphatase = 2.5 x ULN or = 5 x ULN in presence of liver metastases, S. albumin = 30 g/L.• Renal function- Creatinine = 2 ULN, Creatinine clearance > 30 mL/min. 6. Patients should stop any hormonal medication as hormone replacement therapy or progesterone at least one month prior to enrolment. 7. Patients should have at least one measurable lesion by RECIST criteria.

Exclusion Criteria

1. Untreated brain metastases. 2. Patients on strong inhibitor or inducer of isoenzyme CYP3A. 3. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections. 4. Uncontrolled diabetes.5.Patients with grade 3 hypercholesterolemia / hypertriglyceridemia or = grade 2 hypercholesterolemia / hypertriglyceridemia with history of coronary artery disease (despite lipid lowering treatment if given)6. Previous treatment with mTOR inhibitors and/or known hypersensitivity to mTOR inhibitors.7. A known history of Human Immunodeficiency Virus or previous seropositivity for the virus.8. Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture).9. Patients will be excluded if they are on raloxifene or tamoxifen. 10. Patients who have an impairment of gastrointestinal function or who havegastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate[Once at week 4 after starting treatment by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.]

Secondary Outcome Measures

Name	Time	Method
• Overall survival defined as time between signing consent to death from any cause. [Monitored 4 weekly];• Side effects & quality of life.[Monitored on 4 weekly basis till 4 weeks after stopping treatment];• Correlation of outcomes with baseline genomic profile. [Assessed at week 4 after starting treatment.];• Progression free survival- time from signing consent to an event (death from any cause or disease progression).[Monitored 4 weekly]