Lung NeoplasmsLOCALNCT03046316
Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
A study testing local consolidative treatment in people with Lung Neoplasms, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- local consolidative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jul 2026
- Phase
- Interventional
- 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
- Male or female, age >= 18 years, with life expectancy of at least 12 weeks.
- Patients with histologically documented metastatic (stage IV) non-small cell lung cancer.
- Subjected to driving genes examination including EGFR, ALK and ROS1.
- Achieve complete response (CR)/partial response (PR)/stable disease (SD) after front line systemic treatment (chemotherapy, targeted therapy or immunological checkpoint inhibitors).
- Total metastatic lesions is limited to five.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.
Show all 15Show fewer
- Patients must have measurable disease according to the RECIST (version 1.1) criteria.
- Adequate organ function as defined by the following criteria:
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 upper limit of normal (ULN) in the absence of liver metastases or up to 5 ULN in case of liver metastases. Total bilirubin <= 1.5 ULN.
- Bone marrow function: Granulocyte count >= 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin >= 80g/dl.
- Renal function: serum creatinine <= 1.5 ULN or creatinine clearance >= 60 ml/min. (based on modified Cockcroft-Gault formula).
- Adequate coagulating function.
- For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Males must agree to use effective contraception during the study period and for at least 12 weeks after completion of the study treatment.
- Written (signed) informed Consent to participate in the study.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Stage I-III a NSCLC completing radical treatment , then undergoing systemic anti-cancer treatment after recurrence.
- Patients with PFS no more than 3 months. to first line theray.
- Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Prior palliative surgery or other local therapy specifically directed against advanced lung cancer.
- Contraindication for localized treatment including surgery, radiotherapy or interventional therapy judged by physicians.
- Patients with any unstable systemic disease (including active infections, significant cardiovascular disease, any significant hepatic, renal or metabolic disease).
Show all 12Show fewer
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
- Nursing or lactating women.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Patients who has mental disorder or other disease that contribute to no compliance.
- Unwilling to write informed consent to participate in the study.
- Patients who is unwilling to accept the follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guagndong, 510080
ZHEN WANG, PhD, 862083827812 ext. 50811, hunterol@163.com
Huifen Huang, 862083827812 ext. 50810, huifen8839@163.com
About this study
Official title: Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).
Read the detailed description
It is required that pathological diagnosis and genetic profile including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) be established prior to enrollment. Standard front line systemic should be given according to clinical practice. Molecular targeting drugs for patients with driving mutations should be acquired legally. Patients without driving mutations should undergo standard first line chemotherapy and or immunological checkpoint inhibitors. One cycle is three weeks and response evaluation is done every two cycles. CR, PR and SD should be confirmed after four cycles of therapy.
Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.
- Conditions
- Lung Neoplasms
- Being tested
- local consolidative treatment
- Keywords
- Therapeutics, local therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local consolidative treatmentOther
local consolidative treatment to primary or metastases, which includes surgery, radiotherapy or interventional therapy
| Study group | Role | What they receive |
|---|---|---|
| local consolidative treatment | Other | Patients will be referred to multiple disciplinary treatment discussion for the decision of local consolidative treatment to primary or metastatic lesions including surgery, radiotherapy or interventional therapy. Receives: Other: local consolidative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
month
Measured: 8 months
Secondary outcomes (3)
Response rate
percentage(%)
Measured: 6 months
Lung Cancer Symptom Scale
quality of life
Measured: 12 months
overall survival
month
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Jun 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Long Wu, Guangdong Association of Clinical Trials
- Investigators
- Zhen Wang, PhD,MD, Principal investigator, Guangdong General Hospital&Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046316
- Sponsor's protocol ID
- CTONG1602
- Acronym
- LOCAL
- Status last verified
- Jul 2020
- First submitted
- 29 Nov 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.
PubMed 23835708Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
PubMed 26742998Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.
PubMed 7799047Suzuki H, Yoshino I. Approach for oligometastasis in non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):192-6. doi: 10.1007/s11748-016-0630-7. Epub 2016 Feb 19.
PubMed 26895202Shimada Y, Saji H, Kakihana M, Kajiwara N, Ohira T, Ikeda N. Survival outcomes for oligometastasis in resected non-small cell lung cancer. Asian Cardiovasc Thorac Ann. 2015 Oct;23(8):937-44. doi: 10.1177/0218492315596463. Epub 2015 Jul 22.
PubMed 26207006Pan H, Simpson DR, Mell LK, Mundt AJ, Lawson JD. A survey of stereotactic body radiotherapy use in the United States. Cancer. 2011 Oct 1;117(19):4566-72. doi: 10.1002/cncr.26067. Epub 2011 Mar 15.
PubMed 21412761Rusthoven KE, Kavanagh BD, Cardenes H, Stieber VW, Burri SH, Feigenberg SJ, Chidel MA, Pugh TJ, Franklin W, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.
PubMed 19255321Rusthoven KE, Kavanagh BD, Burri SH, Chen C, Cardenes H, Chidel MA, Pugh TJ, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. J Clin Oncol. 2009 Apr 1;27(10):1579-84. doi: 10.1200/JCO.2008.19.6386. Epub 2009 Mar 2.
PubMed 19255320Wronski M, Arbit E, Burt M, Galicich JH. Survival after surgical treatment of brain metastases from lung cancer: a follow-up study of 231 patients treated between 1976 and 1991. J Neurosurg. 1995 Oct;83(4):605-16. doi: 10.3171/jns.1995.83.4.0605.
PubMed 7674008Nakagawa H, Miyawaki Y, Fujita T, Kubo S, Tokiyoshi K, Tsuruzono K, Kodama K, Higashiyama M, Doi O, Hayakawa T. Surgical treatment of brain metastases of lung cancer: retrospective analysis of 89 cases. J Neurol Neurosurg Psychiatry. 1994 Aug;57(8):950-6. doi: 10.1136/jnnp.57.8.950.
PubMed 8057119Jett JR, Schild SE, Kesler KA, Kalemkerian GP. Treatment of small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e400S-e419S. doi: 10.1378/chest.12-2363.
PubMed 23649448Patel AN, Simone CB 2nd, Jabbour SK. Risk factors and management of oligometastatic non-small cell lung cancer. Ther Adv Respir Dis. 2016 Aug;10(4):338-48. doi: 10.1177/1753465816642636. Epub 2016 Apr 8.
PubMed 27060187Barone M, Di Nuzzo D, Cipollone G, Camplese P, Mucilli F. Oligometastatic non-small cell lung cancer (NSCLC): adrenal metastases. Experience in a single institution. Updates Surg. 2015 Dec;67(4):383-7. doi: 10.1007/s13304-015-0336-x. Epub 2015 Nov 20.
PubMed 26589602Raz DJ, Lanuti M, Gaissert HC, Wright CD, Mathisen DJ, Wain JC. Outcomes of patients with isolated adrenal metastasis from non-small cell lung carcinoma. Ann Thorac Surg. 2011 Nov;92(5):1788-92; discussion 1793. doi: 10.1016/j.athoracsur.2011.05.116. Epub 2011 Sep 22.
PubMed 21944257DeLuzio MR, Moores C, Dhamija A, Wang Z, Cha C, Boffa DJ, Detterbeck FC, Kim AW. Resection of oligometastatic lung cancer to the pancreas may yield a survival benefit in select patients--a systematic review. Pancreatology. 2015 Sep-Oct;15(5):456-462. doi: 10.1016/j.pan.2015.03.014. Epub 2015 Apr 3.
PubMed 25900320
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
- ClinicalTrials.gov ID
- NCT03046316
- Acronym / sponsor ID
- LOCAL / CTONG1602
- Conditions
- Lung Neoplasms
- Keywords
- Therapeutics, local therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- 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.
This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).
Detailed description
It is required that pathological diagnosis and genetic profile including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) be established prior to enrollment. Standard front line systemic should be given according to clinical practice. Molecular targeting drugs for patients with driving mutations should be acquired legally. Patients without driving mutations should undergo standard first line chemotherapy and or immunological checkpoint inhibitors. One cycle is three weeks and response evaluation is done every two cycles. CR, PR and SD should be confirmed after four cycles of therapy.
Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| local consolidative treatment | Other | Other: local consolidative treatmentPatients will be referred to multiple disciplinary treatment discussion for the decision of local consolidative treatment to primary or metastatic lesions including surgery, radiotherapy or interventional therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female, age >= 18 years, with life expectancy of at least 12 weeks.
- Patients with histologically documented metastatic (stage IV) non-small cell lung cancer.
- Subjected to driving genes examination including EGFR, ALK and ROS1.
- Achieve complete response (CR)/partial response (PR)/stable disease (SD) after front line systemic treatment (chemotherapy, targeted therapy or immunological checkpoint inhibitors).
- Total metastatic lesions is limited to five.
Key exclusion criteria (12 listed)
- Stage I-III a NSCLC completing radical treatment , then undergoing systemic anti-cancer treatment after recurrence.
- Patients with PFS no more than 3 months. to first line theray.
- Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Prior palliative surgery or other local therapy specifically directed against advanced lung cancer.
- Contraindication for localized treatment including surgery, radiotherapy or interventional therapy judged by physicians.
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 |
|---|---|---|
| local consolidative treatmentlocal consolidative treatment to primary or metastases, which includes surgery, radiotherapy or interventional therapy | Other | local consolidative treatment |
Primary outcome
Progression free survival
Time frame: 8 months
month
3 secondary outcomes
Response rate
Time frame: 6 months
Lung Cancer Symptom Scale
Time frame: 12 months
overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 23835708Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.
- Background: PubMed 26742998Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
- Background: PubMed 7799047Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.
- Background: PubMed 26895202Suzuki H, Yoshino I. Approach for oligometastasis in non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):192-6. doi: 10.1007/s11748-016-0630-7. Epub 2016 Feb 19.
- Background: PubMed 26207006Shimada Y, Saji H, Kakihana M, Kajiwara N, Ohira T, Ikeda N. Survival outcomes for oligometastasis in resected non-small cell lung cancer. Asian Cardiovasc Thorac Ann. 2015 Oct;23(8):937-44. doi: 10.1177/0218492315596463. Epub 2015 Jul 22.
- Background: PubMed 21412761Pan H, Simpson DR, Mell LK, Mundt AJ, Lawson JD. A survey of stereotactic body radiotherapy use in the United States. Cancer. 2011 Oct 1;117(19):4566-72. doi: 10.1002/cncr.26067. Epub 2011 Mar 15.
- Background: PubMed 19255321Rusthoven KE, Kavanagh BD, Cardenes H, Stieber VW, Burri SH, Feigenberg SJ, Chidel MA, Pugh TJ, Franklin W, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.
- Background: PubMed 19255320Rusthoven KE, Kavanagh BD, Burri SH, Chen C, Cardenes H, Chidel MA, Pugh TJ, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. J Clin Oncol. 2009 Apr 1;27(10):1579-84. doi: 10.1200/JCO.2008.19.6386. Epub 2009 Mar 2.
- Background: PubMed 7674008Wronski M, Arbit E, Burt M, Galicich JH. Survival after surgical treatment of brain metastases from lung cancer: a follow-up study of 231 patients treated between 1976 and 1991. J Neurosurg. 1995 Oct;83(4):605-16. doi: 10.3171/jns.1995.83.4.0605.
- Background: PubMed 8057119Nakagawa H, Miyawaki Y, Fujita T, Kubo S, Tokiyoshi K, Tsuruzono K, Kodama K, Higashiyama M, Doi O, Hayakawa T. Surgical treatment of brain metastases of lung cancer: retrospective analysis of 89 cases. J Neurol Neurosurg Psychiatry. 1994 Aug;57(8):950-6. doi: 10.1136/jnnp.57.8.950.
- Background: PubMed 23649448Jett JR, Schild SE, Kesler KA, Kalemkerian GP. Treatment of small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e400S-e419S. doi: 10.1378/chest.12-2363.
- Background: PubMed 27060187Patel AN, Simone CB 2nd, Jabbour SK. Risk factors and management of oligometastatic non-small cell lung cancer. Ther Adv Respir Dis. 2016 Aug;10(4):338-48. doi: 10.1177/1753465816642636. Epub 2016 Apr 8.
- Individual participant dataSharing planned: No
Related trials for Lung Neoplasms
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Zhen Wang, PhD,MD principal investigator
Guangdong General Hospital&Guangdong Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local consolidative treatment in people with Lung Neoplasms, run by Guangdong Association of Clinical Trials at 1 site in China.
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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZHEN WANG, PhD,MD (+8683827812 ext. 50811, hunterol@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046316, which also lists 17 linked publications.
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 23 Jul 2020.