Exemestane in Post-Menopausal Women With NSCLC

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT02666105

Run by

Masonic Cancer Center, University of Minnesota

People needed

6

Starts

2018-09-27

Expected to finish

2022-02-28

Last updated by the study team

2023-05-31

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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
• AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
• Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min
• Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e. peripheral neuropathy) is permitted.
• A minimum time period must elapse between the end of a previous treatment and start of study therapy:
• 1 week from the completion of radiation therapy for brain metastases
• 4 weeks from the completion of chemotherapy or any experimental therapy
• 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury)
• Voluntary written consent before any research related procedures or therapy

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

Where it is running

• Mayo Clinic Health System — Albert Lea, Minnesota, United States
• Essentia Health St. Joseph's Medical Center — Brainerd, Minnesota, United States
• Essentia Health Deer River — Deer River, Minnesota, United States
• Essentia Health St. Mary's Detroit Lakes — Detroit Lakes, Minnesota, United States
• Essentia Health Cancer Center — Duluth, Minnesota, United States
• Essentia Health Fosston — Fosston, Minnesota, United States
• Fairview Grand Itasca Clinic & Hospital — Grand Rapids, Minnesota, United States
• Essentia Health Hibbing — Hibbing, Minnesota, United States
• Fairview Range Medical Center — Hibbing, Minnesota, United States
• Mayo Clinic Health System — Mankato, Minnesota, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• Monticello Cancer Center (MMCORC) — Monticello, Minnesota, United States
• Essentia Health Park Rapids — Park Rapids, Minnesota, United States
• Fairview Northland Medical Center — Princeton, Minnesota, United States
• Essentia Health Sandstone — Sandstone, Minnesota, United States
• Sanford Thief River Falls Medical Center — Thief River Falls, Minnesota, United States
• Essentia Health Virginia — Virginia, Minnesota, United States
• Sanford Worthington Medical Center — Worthington, Minnesota, United States

Full record on ClinicalTrials.gov

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