Non Small Cell Lung CancerEarly Phase 1NCT03574220
Pembrolizumab After Lung SBRT for Medically Inoperable Early Stage Non-small Cell Lung Cancer
A Early Phase 1 study testing Pembrolizumab and Stereotactic body radiotherapy in people with Non Small Cell Lung Cancer, run by Case Comprehensive Cancer Center.
Trial summary
The purpose of this study is to see whether patients who have early stage NSCLC bigger than a certain size might benefit from receiving additional medicinal drug to treat their cancer after the SBRT Surgeons and radiation doctors have understood for some time that the chances of cancer showing up in areas outside the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Pembrolizumab and Stereotactic body radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2019to 21 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed T1b-T3N0M0 (stage IA-IIB) NSCLC, which have been judged to be medically inoperable and will have undergone a course of lung SBRT will be enrolled in this trial. Eligible patients who will have completed lung SBRT will have had appropriate staging studies identifying them as specific subsets of American Joint Committee on Cancer (AJCC) 7th edition stage I or stage II based on only one of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging using size criteria:
- A. T2a (>3cm, < 5cm) N0 M0, Stage IB
- B. T2b (>5 cm, < 7cm) N0 M0, Stage IIA
- C. T3 (>7cm) N0 M0, Stage IIB
- In order to be eligible for participation in this trial, the subject must:
- Be willing and able to provide written informed consent/assent for the trial.
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- Have measurable or unmeasurable disease based on RECIST 1.1.
- Be willing to provide archival tissue from a tumor lesion.
- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- All screening labs should be performed within 10 days of treatment initiation.
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9g/dL or ≥5.6mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment
- Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 60 mL/min for subjects with creatinine levels > 1.5 times ULN
- Serum total bilirubin ≤ 1.5 times ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- aspartate aminotransferase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN for subjects with liver metastases
- Albumin ≥ 2.5mg/dL
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 120 days after the last dose of study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Male subjects of childbearing potential must agree to use an adequate method of contraception - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Who cannot join
- Has received lung SBRT for stage IA disease, or for any T2 primary tumors involving the main bronchus, 2 cm of more distal to the carina; or with associated with atelectasis that extends to the hilar region; or for any T3 tumors that invade the chest wall, mediastinal pleura, diaphragm, phrenic nerve, parietal pericardium, tumor or the main bronchus less than 2 cm distal to the carina; atelectasis of the entire lung; or with separate tumor nodule(s) in the same lobe.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active Bacillus Tuberculosis (TB).
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had any prior chemotherapy or targeted small molecule therapy for the currently diagnosed cancer.
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- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (HCV).
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
About this study
Official title: A Pilot Study of Adjuvant Pembrolizumab After Lung Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to see whether patients who have early stage NSCLC bigger than a certain size might benefit from receiving additional medicinal drug to treat their cancer after the SBRT Surgeons and radiation doctors have understood for some time that the chances of cancer showing up in areas outside the chest are higher for patients with tumors bigger than 3 cm, (about 1 ¼ inches). However, it is not routine to offer chemotherapy or drug treatments after radiation or surgery for lung cancer for patients with early stage lung cancer. This is because giving extra treatment in the form of chemotherapy has not shown to help patients live longer. There has been reluctance to offer additional treatments, especially chemotherapy, to patients with lung cancer who could not have surgery because of their medical issues. Even if these patients were felt to be at a higher risk of their cancer coming back, there is hesitation because the treatments can be difficult to tolerate in frail patients.
Recently, there have been very important advances in the kinds of drug therapy that are used for lung cancer patients. These kinds of drugs are called immunotherapy since they work with the body's immune system to fight the cancer. These drugs have been shown to make patients with advanced, incurable lung cancer, live longer and also to be very safe with very limited side effects. Because of these favorable characteristics, cancer specialists are interested in using these drugs for patients with curable cancer and for patients who may be too fragile for traditional chemotherapy. In this way, patients who get SBRT are already known to be fragile so cancer doctors are interested in now studying this kind of drug in SBRT patients to see if it can make patients with large tumors do better. The idea of the study then is that the patient would receive their standard SBRT and if their tumor is of a certain size that makes the risk of the cancer showing up outside the chest higher than routine, they would be considered for getting the immunotherapy drug.
Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of head and neck cancer. However, it has not been approved for use in other cancers such as newly diagnosed early stage NSCLC. It is FDA approved for advanced NSCLC, that is people who have already had some chemotherapy and their disease has worsened. Pembrolizumab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.
Read the detailed description
The primary objective of this pilot safety study is to determine the tolerability and feasibility of administering pembrolizumab in the adjuvant setting following completion of definitive SBRT to the lung for patients with medically inoperable early stage NSCLC with tumors greater than 3 cm in diameter
Secondary Objectives
- Distant metastases free survival (DMFS)
- Disease Free Survival (DFS)
- Overall survival (OS)
Study design including dose escalation / cohorts
This is an open-label, single arm feasibility study of lung SBRT followed 2 to 4 weeks after completion by the addition of pembrolizumab.
Eligible patients will have biopsy-confirmed T1b-T3N0M0 (stage IA-IIB) non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC NOS), performance status 0-2, deemed medically inoperable by a thoracic surgeon or pulmonologist, and no contraindications to pembrolizumab.
The primary endpoint for this study is safety and feasibility. For the first stage of this study, 8 patients will be enrolled. If >7 of the initial 8 patients complete the therapy without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity, an additional 7 patients will be enrolled for a total of 15 patients. If >2 of the original 8 patients (>25%) experience a Grade >3 pulmonary toxicity or any Grade >4 toxicity the trial will be closed and the study therapy will be considered too toxic. If >4 of 15 patients (>26.7%) experience a Grade >3 pulmonary toxicity or any Grade >4 toxicity, the study drug regimen will be deemed too toxic and unsafe. If >12 out of 15 patients complete the study without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity, the study drug regimen will be considered safe and feasible for further study.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pembrolizumab, Stereotactic body radiotherapy
- Keywords
- pembrolizumab, radiotherapy, immunotherapy
- 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.
PembrolizumabDrug
Also called Keytruda
200mg IV every 21 days over 6 months
Stereotactic body radiotherapyRadiation
50 Grays (Gy) in 5 fractions over 5-14 days, or 60 Gy in 3 fractions over 8-14 days
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Stereotactic Body Radiotherapy | Experimental | Lung SBRT 50 Grays (Gy) in 5 fractions over 5-14 days, or 60 Gy in 3 fractions over 8-15 days.
Adjuvant Therapy:
Pembrolizumab 200mg IV every 21 days for 6 months Receives: Drug: Pembrolizumab; Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients tolerant to study drug
<60% of patients being able to complete the scheduled doses of study drug without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity. Good tolerability had been defined as >90% of patients being able to complete the scheduled doses of study drug without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity.
Measured: Up to 12 months
Secondary outcomes (4)
Duration of Distant metastases free survival (DMFS)
DMFS is defined as the time from initiation of study drug post-SBRT, until the first documented, confirmed distant-only [non local, non-regional nodal] progression of disease. DMFS will be measured and reported from the initiation of SBRT.
Measured: Up to 5 years
Duration of Disease Free Survival
DFS is defined as the time from initiation of study drug post-SBRT that the patient survives without any signs or symptoms of that cancer. DFS will also be measured and reported from the initiation of SBRT.
Measured: Up to 5 years
Duration of Overall Survival
OS will be measure from the initiation of SBRT until death.
Measured: Up to 5 years
Duration of Local control
For the purpose of the study, local control will be defined as a complete response, partial response, or stable disease within the planning target volume. The duration of local control will be measured from the time of SBRT initiation.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start19 Feb 2019
- Primary completion21 Mar 2020
- Study completion21 Mar 2020
Why it stopped: No accrual - closed by PRMC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Videtic, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574220
- Sponsor's protocol ID
- CASE7516
- Status last verified
- Apr 2020
- First submitted
- 20 Jun 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adjuvant Pembrolizumab After Lung Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03574220
- Acronym / sponsor ID
- CASE7516
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- pembrolizumab, radiotherapy, immunotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual - closed by PRMC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see whether patients who have early stage NSCLC bigger than a certain size might benefit from receiving additional medicinal drug to treat their cancer after the SBRT Surgeons and radiation doctors have understood for some time that the chances of cancer showing up in areas outside the chest are higher for patients with tumors bigger than 3 cm, (about 1 ¼ inches). However, it is not routine to offer chemotherapy or drug treatments after radiation or surgery for lung cancer for patients with early stage lung cancer. This is because giving extra treatment in the form of chemotherapy has not shown to help patients live longer. There has been reluctance to offer additional treatments, especially chemotherapy, to patients with lung cancer who could not have surgery because of their medical issues. Even if these patients were felt to be at a higher risk of their cancer coming back, there is hesitation because the treatments can be difficult to tolerate in frail patients.
Recently, there have been very important advances in the kinds of drug therapy that are used for lung cancer patients. These kinds of drugs are called immunotherapy since they work with the body's immune system to fight the cancer. These drugs have been shown to make patients with advanced, incurable lung cancer, live longer and also to be very safe with very limited side effects. Because of these favorable characteristics, cancer specialists are interested in using these drugs for patients with curable cancer and for patients who may be too fragile for traditional chemotherapy. In this way, patients who get SBRT are already known to be fragile so cancer doctors are interested in now studying this kind of drug in SBRT patients to see if it can make patients with large tumors do better. The idea of the study then is that the patient would receive their standard SBRT and if their tumor is of a certain size that makes the risk of the cancer showing up outside the chest higher than routine, they would be considered for getting the immunotherapy drug.
Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of head and neck cancer. However, it has not been approved for use in other cancers such as newly diagnosed early stage NSCLC. It is FDA approved for advanced NSCLC, that is people who have already had some chemotherapy and their disease has worsened. Pembrolizumab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.
Detailed description
The primary objective of this pilot safety study is to determine the tolerability and feasibility of administering pembrolizumab in the adjuvant setting following completion of definitive SBRT to the lung for patients with medically inoperable early stage NSCLC with tumors greater than 3 cm in diameter
Secondary Objectives
- Distant metastases free survival (DMFS)
- Disease Free Survival (DFS)
- Overall survival (OS)
Study design including dose escalation / cohorts
This is an open-label, single arm feasibility study of lung SBRT followed 2 to 4 weeks after completion by the addition of pembrolizumab.
Eligible patients will have biopsy-confirmed T1b-T3N0M0 (stage IA-IIB) non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC NOS), performance status 0-2, deemed medically inoperable by a thoracic surgeon or pulmonologist, and no contraindications to pembrolizumab.
The primary endpoint for this study is safety and feasibility. For the first stage of this study, 8 patients will be enrolled. If >7 of the initial 8 patients complete the therapy without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity, an additional 7 patients will be enrolled for a total of 15 patients. If >2 of the original 8 patients (>25%) experience a Grade >3 pulmonary toxicity or any Grade >4 toxicity the trial will be closed and the study therapy will be considered too toxic. If >4 of 15 patients (>26.7%) experience a Grade >3 pulmonary toxicity or any Grade >4 toxicity, the study drug regimen will be deemed too toxic and unsafe. If >12 out of 15 patients complete the study without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity, the study drug regimen will be considered safe and feasible for further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Stereotactic Body Radiotherapy | Experimental | Drug: Pembrolizumab, Radiation: Stereotactic body radiotherapyLung SBRT 50 Grays (Gy) in 5 fractions over 5-14 days, or 60 Gy in 3 fractions over 8-15 days. Adjuvant Therapy: Pembrolizumab 200mg IV every 21 days for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed T1b-T3N0M0 (stage IA-IIB) NSCLC, which have been judged to be medically inoperable and will have undergone a course of lung SBRT will be enrolled in this trial. Eligible patients who will have completed lung SBRT will have had appropriate staging studies identifying them as specific subsets of American Joint Committee on Cancer (AJCC) 7th edition stage I or stage II based on only one of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging using size criteria:
- Be willing and able to provide written informed consent/assent for the trial.
- Have measurable or unmeasurable disease based on RECIST 1.1.
- Be willing to provide archival tissue from a tumor lesion.
- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Key exclusion criteria (17 listed)
- Has received lung SBRT for stage IA disease, or for any T2 primary tumors involving the main bronchus, 2 cm of more distal to the carina; or with associated with atelectasis that extends to the hilar region; or for any T3 tumors that invade the chest wall, mediastinal pleura, diaphragm, phrenic nerve, parietal pericardium, tumor or the main bronchus less than 2 cm distal to the carina; atelectasis of the entire lung; or with separate tumor nodule(s) in the same lobe.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active Bacillus Tuberculosis (TB).
- Hypersensitivity to pembrolizumab or any of its excipients.
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda200mg IV every 21 days over 6 months | Drug | Pembrolizumab + Stereotactic Body Radiotherapy |
| Stereotactic body radiotherapy50 Grays (Gy) in 5 fractions over 5-14 days, or 60 Gy in 3 fractions over 8-14 days | Radiation | Pembrolizumab + Stereotactic Body Radiotherapy |
Primary outcome
Percent of patients tolerant to study drug
Time frame: Up to 12 months
<60% of patients being able to complete the scheduled doses of study drug without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity. Good tolerability had been defined as >90% of patients being able to complete the scheduled doses of study drug without experiencing a Grade >3 pulmonary toxicity or any Grade >4 toxicity.
4 secondary outcomes
Duration of Distant metastases free survival (DMFS)
Time frame: Up to 5 years
Duration of Disease Free Survival
Time frame: Up to 5 years
Duration of Overall Survival
Time frame: Up to 5 years
Duration of Local control
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
Gregory Videtic, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pembrolizumab and Stereotactic body radiotherapy in people with Non Small Cell Lung Cancer, run by Case Comprehensive Cancer Center.
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 22 inclusion and 17 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: withdrawn, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent of patients tolerant to study drug (time frame: Up to 12 months). 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 7 Apr 2020.