Exemestane in Post-Menopausal Women With NSCLC

NCT02666105 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2015LS095
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 18

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).

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (3)

• Toxicity Assessment

  Post Treatment Day 30

• Progression-free Survival

  1 year after enrollment

• Quality of Life Assessment

  Baseline, Treatment, End of Treatment, and 1 Month Post-Treatment

Study Arms (1)

Exemestane Therapy

EXPERIMENTAL

Drug: Exemestane

Interventions

Exemestane DRUG

One 25 mg tablet once daily for a minimum of 6 weeks

Also known as: Aromasin

Exemestane Therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab) NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
• Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase - tumor block or a minimum of 5 unstained slides
• Failed at least 1 prior FDA approved treatment for advanced NSCLC. Patients with EGFR/ALK/ROS1 rearrangements should have received an FDA-approved TKI prior to enrollment on this trial.
• Measureable disease by RECIST version 1.1
• Post-menopausal defined as
• Age ≥ 55 years and 1 year or more of amenorrhea
• Age \< 55 years and 1 year or more of amenorrhea with an estradiol assay \< 20 pg/mL
• Surgical menopause with bilateral oophorectomy
• ECOG performance status 0, 1 or 2
• \* Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record
• Adequate organ function within 14 days of study enrollment defined as:
• Hematology:
• \*\* Absolute neutrophil count (ANC) ≥ 1500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 8 g/dL
• Biochemistry:
• Total Bilirubin within normal institutional limits

You may not qualify if:

• Known active CNS disease - If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery - patients should be neurologically stable and requiring ≤10mg oral prednisone equivalence of steroids per day
• Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2
• Requiring \> 10 mg prednisone equivalence of steroids per day for immune-related toxicity
• Inability or unwilling to swallow study drug
• Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
• Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
• Known hypersensitivity to exemestane or its excipients
• Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
• Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval
• Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (18)

Mayo Clinic Health System

Albert Lea, Minnesota, 56007, United States

Location

Essentia Health St. Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Essentia Health Deer River

Deer River, Minnesota, 56636, United States

Location

Essentia Health St. Mary's Detroit Lakes

Detroit Lakes, Minnesota, 56501, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Essentia Health Fosston

Fosston, Minnesota, 56542, United States

Location

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, 55744, United States

Location

Essentia Health Hibbing

Hibbing, Minnesota, 55746, United States

Location

Fairview Range Medical Center

Hibbing, Minnesota, 55746, United States

Location

Mayo Clinic Health System

Mankato, Minnesota, 56001, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Monticello Cancer Center (MMCORC)

Monticello, Minnesota, 55362, United States

Location

Essentia Health Park Rapids

Park Rapids, Minnesota, 56470, United States

Location

Fairview Northland Medical Center

Princeton, Minnesota, 55731, United States

Location

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

Location

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States

Location

Essentia Health Virginia

Virginia, Minnesota, 55792, United States

Location

Sanford Worthington Medical Center

Worthington, Minnesota, 56187, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

exemestane

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Manish Patel, DO
• Organization: University of Minnesota

patel069@umn.edu

612-625-2654

Study Officials

• Manish Patel, DO

  University of Minnesota Masonic Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 28, 2016
• Study Start: September 27, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-05

Locations

US (18)