A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Overview

About this study

This study is being conducted to see if adding Exemestane to the immune checkpoint blockade can slow disease progression in post-menopausal women with non-small cell lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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. 
  • 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.

Exclusion 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 (e.g., 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Albert Lea, Minn.

Mayo Clinic principal investigator

Mina Hanna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Stephan Thome, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Stephan Thome, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Stephan Thome, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20480295

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