Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Menopause

Antineoplastic Agents

All Drugs and Chemicals

Exemestane

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

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

Manish Patel, DO

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).

Exemestane in Post-Menopausal Women With NSCLC

Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

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.

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 will be assessed until 1 year after study enrollment based on the definitions found in RECIST 1.1

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.

Masonic Cancer Center, University of Minnesota

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

Exemestane Therapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Disease Response (RECIST)

Toxicity Assessment

Progression-free Survival

Exemestane Therapy - Baseline

Quality of life assessment at three weeks of treatment.

Exemestane Therapy - 3 Weeks

Quality of life assessment at six weeks of treatment.

Exemestane Therapy - 6 Weeks

Quality of life assessment at nine weeks of treatment.

Exemestane Therapy - 9 Weeks

Quality of life assessment at twelve weeks of treatment.

Exemestane Therapy - 12 Weeks

Quality of life assessment at fifteen weeks of treatment.

Exemestane Therapy - 15 Weeks

Quality of life assessment at end of treatment, eighteen weeks of treatment.

Exemestane Therapy - 18 Weeks

Quality of life assessment one month post-treatment.

Spots Global Cancer Trial Database for Exemestane in Post-Menopausal Women With NSCLC

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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