This is a phase II therapeutic study of adding exemestane therapy in post-menopausal women with advanced non-small cell lung cancer (NSCLC) who are progressing while on treatment with an immune checkpoint antibody (pembrolizumab, atezolizumab, or nivolumab).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
One 25 mg tablet once daily for a minimum of 6 weeks
Mayo Clinic Health System
Albert Lea, Minnesota, United States
Essentia Health St. Joseph's Medical Center
Brainerd, Minnesota, United States
Disease Response (RECIST)
Initial disease response will be assessed from 6 weeks to 1 year after the start of exemestane using the Response Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 6 weeks
Toxicity Assessment
Toxicity will be assessed from the 1st dose to Post Treatment Day 30, up to 22 weeks. Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.
Time frame: Post Treatment Day 30
Progression-free Survival
progression-free survival will be assessed until 1 year after study enrollment based on the definitions found in RECIST 1.1
Time frame: 1 year after enrollment
Quality of Life Assessment
Quality of life will be assessed by use of Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) at baseline, every 3 weeks from the 1st dose to Post Treatment Day 30, up to 22 weeks. Patient's report on a number of subjects on a 0-10 scale. The scores range from 28 to 150. 50 is the average score, 28 is the best health and 150 is the worst health.
Time frame: Baseline, Treatment, End of Treatment, and 1 Month Post-Treatment
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