Exemestane in Post-Menopausal Women With NSCLC

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedExemestane

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 31, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Masonic Cancer Center, University of Minnesota

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Masonic Cancer Center, University of Minnesota
Interventions being studied: Drug: Exemestane

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic Health SystemAlbert Lea, Minnesota
Essentia Health St. Joseph's Medical CenterBrainerd, Minnesota
Essentia Health Deer RiverDeer River, Minnesota
Essentia Health St. Mary's Detroit LakesDetroit Lakes, Minnesota
Essentia Health Cancer CenterDuluth, Minnesota
Essentia Health FosstonFosston, Minnesota
Fairview Grand Itasca Clinic & HospitalGrand Rapids, Minnesota
Essentia Health HibbingHibbing, Minnesota
Fairview Range Medical CenterHibbing, Minnesota
Mayo Clinic Health SystemMankato, Minnesota
Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota
Monticello Cancer Center (MMCORC)Monticello, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 31, 2023. Always confirm current availability with the study team.

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