Exemestane in Post-Menopausal Women With NSCLC

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Exemestane

• Registration Number: NCT02666105
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2018-09-27
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Results First Submitted: 2023-03-31
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Results First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exemestane Therapy	Exemestane	-

Primary Outcome Measures

Name	Time	Method
Disease Response (RECIST)	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Toxicity Assessment	Post Treatment Day 30	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.
Progression-free Survival	1 year after enrollment	progression-free survival will be assessed until 1 year after study enrollment based on the definitions found in RECIST 1.1
Quality of Life Assessment	Baseline, Treatment, End of Treatment, and 1 Month Post-Treatment	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.

Trial Locations

Locations (17)

Essentia Health Hibbing; 🇺🇸 Hibbing, Minnesota, United States

Mayo Clinic Health System; 🇺🇸 Mankato, Minnesota, United States

Essentia Health Park Rapids; 🇺🇸 Park Rapids, Minnesota, United States

Essentia Health St. Joseph's Medical Center; 🇺🇸 Brainerd, Minnesota, United States

Essentia Health Virginia; 🇺🇸 Virginia, Minnesota, United States

Fairview Grand Itasca Clinic & Hospital; 🇺🇸 Grand Rapids, Minnesota, United States

Essentia Health Sandstone; 🇺🇸 Sandstone, Minnesota, United States

Monticello Cancer Center (MMCORC); 🇺🇸 Monticello, Minnesota, United States

Essentia Health Cancer Center; 🇺🇸 Duluth, Minnesota, United States

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Essentia Health St. Mary's Detroit Lakes; 🇺🇸 Detroit Lakes, Minnesota, United States

Essentia Health Deer River; 🇺🇸 Deer River, Minnesota, United States

Essentia Health Fosston; 🇺🇸 Fosston, Minnesota, United States

Fairview Range Medical Center; 🇺🇸 Hibbing, Minnesota, United States

Fairview Northland Medical Center; 🇺🇸 Princeton, Minnesota, United States

Sanford Thief River Falls Medical Center; 🇺🇸 Thief River Falls, Minnesota, United States

Sanford Worthington Medical Center; 🇺🇸 Worthington, Minnesota, United States