A Phase II Trial of Combined PKCiota and mTOR Inhibition as Maintenance Therapy for Patients With Stage IV Squamous Histology NSCLC Without Progression Following at Least Four Cycles of First-line Platinum Containing Chemotherapy
I. To assess the progression-free survival at four months of patients treated with
maintenance auranafin plus sirolimus after non-progression on first line platinum based
chemotherapy for stage IV squamous histology non-small cell lung cancer (NSCLC).
I. To assess the overall survival in this population in comparison to recent historical
controls (exemplified by survival of the squamous histology cohort of the Scagliotti et al
trial of cisplatin with pemetrexed or gemcitabine for advanced NSCLC).
II. To determine the adverse events (AE) profile and safety of the regimen. III. To
determine the overall response rate, per Response Evaluation Criteria in Solid Tumors
(RECIST) criteria, and duration of tumor response in this population in patients with
I. To assess the relationship between molecular correlates and progression free survival
(PFS), overall survival (OS), response and toxicity.
Patients receive auranofin and sirolimus orally (PO) on days 1-28 of each cycle. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for up to 2
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate measured by survival out to 4 months.
A patient is considered to be a 4-month progression-free survivor, or success, if the patient is 4 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Additionally, an estimate and confidence interval for the 4-month progression-free survival rate incorporating censoring may be computed using the method of Kaplan-Meier.
At 4 months
Mayo Clinic in Arizona
United States: Food and Drug Administration
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|