Non-Small Cell Lung CancerPhase 2NCT02666105
Exemestane in Post-Menopausal Women With NSCLC
A Phase 2 study testing Exemestane in people with Non-Small Cell Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 18 sitesUnited States
- Study dates
- 27 Sep 2018to 28 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Mayo Clinic Health System
Albert Lea, Minnesota, 56007
Essentia Health St. Joseph's Medical Center
Brainerd, Minnesota, 56401
Essentia Health Deer River
Deer River, Minnesota, 56636
Essentia Health St. Mary's Detroit Lakes
Detroit Lakes, Minnesota, 56501
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Fosston
Fosston, Minnesota, 56542
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
Essentia Health Hibbing
Hibbing, Minnesota, 55746
Fairview Range Medical Center
Hibbing, Minnesota, 55746
Mayo Clinic Health System
Mankato, Minnesota, 56001
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Monticello Cancer Center (MMCORC)
Monticello, Minnesota, 55362
Essentia Health Park Rapids
Park Rapids, Minnesota, 56470
Fairview Northland Medical Center
Princeton, Minnesota, 55731
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Essentia Health Virginia
Virginia, Minnesota, 55792
Sanford Worthington Medical Center
Worthington, Minnesota, 56187
About this study
Official title: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer
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
- Being tested
- Exemestane
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Aromasin
One 25 mg tablet once daily for a minimum of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exemestane Therapy | Experimental | Not described Receives: Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
Toxicity Assessment
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.
Measured: Post Treatment Day 30
Progression-free Survival
progression-free survival will be assessed until 1 year after study enrollment based on the definitions found in RECIST 1.1
Measured: 1 year after enrollment
Quality of Life Assessment
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.
Measured: Baseline, Treatment, End of Treatment, and 1 Month Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start27 Sep 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Patel, DO, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666105
- Sponsor's protocol ID
- 2015LS095
- Status last verified
- May 2023
- First submitted
- 22 Jan 2016
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02666105
- Acronym / sponsor ID
- 2015LS095
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 31 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane Therapy | Experimental | Drug: Exemestane |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExemestaneAlso: AromasinOne 25 mg tablet once daily for a minimum of 6 weeks | Drug | Exemestane Therapy |
Primary outcome
Disease Response (RECIST)
Time frame: 6 weeks
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.
3 secondary outcomes
Toxicity Assessment
Time frame: Post Treatment Day 30
Progression-free Survival
Time frame: 1 year after enrollment
Quality of Life Assessment
Time frame: Baseline, Treatment, End of Treatment, and 1 Month Post-Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Patel, DO principal investigator
Masonic Cancer Center, University of Minnesota
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exemestane in people with Non-Small Cell Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Response (RECIST) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.