Non-Small Cell Lung Cancer (NSCLC)NCT03559647
The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
An observational study of Non-Small Cell Lung Cancer (NSCLC), run by Hoffmann-La Roche at 94 sites in Germany.
Trial summary
Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Atezolizumab
- How many people
- 358 participants
- Where
- 94 sitesGermany
- Study dates
- 30 May 2018to 20 Aug 2023
- Phase
- Observational
- 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
Study population: Eligible are participants with locally advanced or metastatic NSCLC after prior chemotherapy, who have been chosen by their treating physicians to receive atezolizumab according to the current Summary of Product Characteristics (SmPC) of TECENTRIQ
Who may be able to join
- Diagnosis of locally advanced or metastatic NSCLC (histologically or cytologically confirmed stage IIIB/stage IV) and prior chemotherapy
- Decision to be treated with Atezolizumab according to Summary of Product Characteristics (SmPC) by treating physician, independent of this non-interventional study
- No contraindication to treatment with Atezolizumab
- Retrospective Inclusion:
- Participants may be included retrospectively. Retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with Atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. Quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started Atezolizumab therapy more than 9 weeks prior to ICF being obtained may not be included in the study.
- Participants who give consent to be retrospectively enrolled but have already discontinued Atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of Atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria.
Who cannot join
- Patients not eligible for Atezolizumab treatment according to SmPC
Trial locations and contacts
94 sites in 1 country.
94 sites in 1 country
Germany94 sites
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, 63739
Studienzentrum Aschaffenburg
Aschaffenburg, 63739
Zentralklinikum Augsburg
Augsburg, 86156
Dres. Helmut Tanzer Joachim Hornberger und Johannes Kern
Bad Reichenhall, 83435
Klinikum Mittelbaden; Medizinisches Versorgungszentrum - Hämatologie und Onkologie
Baden-Baden, 76530
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
Bamberg, 96049
St. Hedwig Kliniken Berlin GmbH
Berlin, 10115
Onkologisches Versorgungszentrum Friedrichshain; Hämatologie, Onkologie und Palliativmedizin
Berlin, 10407
Praxis Dr. Med. Gunhild Kühn
Berlin, 10715
Onkologie am Segelfliegerdamm
Berlin, 12487
Klinikum Bielefeld Mitte Klinik für Hämatologie, Onkologie u. Palliativmedizin
Bielefeld, 33604
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
Bielefeld, 33604
Augusta Kranken-Anstalt gGmbH
Bochum, 44791
Klinikum Koeln-Merheim; Lungenklinik
Cologne, 51109
Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
Coswig, 01640
Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
Donauwörth, 86609
Medizinische Klinik Nord, Lungenkrebszentrum
Dortmund, 44145
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307
Klinik St.Johannes-Hospital Medizinische Klinik I
Duisburg, 47166
Klinikum Barnim GmbH; Med. Klinik I, Gastroenterologie, Hämatologie, Onkologie
Eberswalde, 16225
Dres. Bruch, Buschmann, Linck
Euskirchen, 53879
Hämatologisch-Onkologische Fachpraxis Dr. med. Th. Ehlers & Dr. med. N. Karapanagiotidis
Frankenthal/Pfalz, 67227
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt, 60590
St. Elisabethen Krankenhaus
Frankfurt am Main, 60487
Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
Frankfurt am Main, 65929
Dres.Jochen Wilke und Harald Wagner
Fürth, 90766
Fachübergreifende Gemeinschaftspraxis Onkologie & Innere Medizin Dr. med. Haddadin & Panagiotou
Garbsen, 30827
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124
SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
Gera, 07548
Agaplesion Pneumologische Klinik Waldhof Elgershausen; Pneumologie
Greifenstein, 35753
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927
Diakoniekrankenhaus Halle; Klinik für Pneumologie
Halle, 06114
Praxis für Hämatologie und Onkologie in Hamburg
Hamburg, 20251
OncoResearch Lerchenfeld GmbH
Hamburg, 22081
Kath. Marienkrankenhaus gGmbH
Hamburg, 22087
Hämatologische-Onkologische Schwerpunktpraxis
Hamburg, 22457
Dres.Andreas Karcher und Stefan Fuxius
Heidelberg, 69115
Onkologische Praxis in Heidenheim
Heidenheim, 89522
Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper
Hof, 95028
Klinikum Idar-Oberstein; Klinik für Neurochirurgie
Idar-Oberstein, 55743
Klinikum Konstanz; MVZ Onkologie
Konstanz, 78464
MVZ Hämatologie und Onkologie Krefeld
Krefeld, 47805
Internistische Praxis Hämatologie und Onkologie
Kronach, 96317
Klinikum Landshut Medizinische Klinik I
Landshut, 84034
Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
Lebach, 66822
Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
Lehrte, 31275
Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
Leipzig, 04103
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
Leipzig, 04103
Bonifatius Hospital Lingen gGmbH; Hämatologie und Onkologie
Lingen, 49808
Lungenklinik Lostau
Lostau, 39291
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562
Klinikum Ludwigsburg; Studiensekretariat
Ludwigsburg, 71640
Klinikum Magdeburg gGmbH; Klinik für Hämatologie, Onkologie und Palliativmedizin
Magdeburg, 39130
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
Marburg, 35037
Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
Marburg, 35043
Praxis für Innere Medizin und Pneumologie
Markkleeberg, 04416
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
Mayen, 56727
Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie
Minden, 32429
Gem.Praxis im Ärztezentrum Dr.med.Jörg Wiegand Jochen Eggert
Moers, 47441
Klinikum der Universität München; Medizinische Innenstadt
München, 80336
Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
Mutlangen, 73557
Praxis Dr. Uhlig, Naunhof
Naunhof, 04683
Friedrich-Ebert-Krankenhaus Klinik f. Hämatologie/ Onkologie u. Nephrologie
Neumünster, 24534
Ruppiner Kliniken Medizinische Klinik A
Neuruppin, 16816
Praxis Dr. Losem
Neuss, 41462
Praxis für Hämatologie und Onkologie
Neuwied, 56564
Klinikum Nuernberg Nord; Medizinische Klinik 3, Pneumologie, Oncologie
Nuremberg, 90419
Pitri.Studien-GmbH (Ambulantes Therapiezentrum Hämatolgie/ Onkolgogie) Ärztehause 4 OG
Offenburg, 77654
Sana Kliniken Ostholtstein; Klinik Oldenburg; Innere Medizin; Onkologie
Oldenburg, 23758
Paracelsus-Klinik; Abteilung Haematologie und Onkologie
Osnabrück, 49076
Onkologische Studien GbR, Dres. Becker, Kreisel-Büstgens und Moorahrend
Porta Westfalica, 32457
Praxis für Hämatologie & Onkologie
Saarbrücken, 66113
Schwerpunktpraxis für Hämatologie und Onkologie Dr. Med. Thomas Edelmann
Schkeuditz, 04435
Zentrum Ambulante Onkologie
Schorndorf, 73614
Zentrum für ambulante Hämatologie und Onkologie; Onkologische Praxis
Siegburg, 53721
Onkologische Schwerpunktpraxis
Soest, 59494
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
Stade, 21680
Medizinisches Versorgungszentrum Stolberg
Stolberg, 52222
Praxisnetzwerk Hämatologie und InternistischeIOnkologie
Troisdorf, 53840
Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
Tübingen, 72076
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, 89081
SHG-Kliniken Völklingen
Völklingen, 66333
Regio Klinikum Wedel; Pneumologie
Wedel, 22880
Praxis innere Medizin; Onkologie
Weimar, 99425
MedFISMO ltd.
Weinsberg, 74189
Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
Westerstede, 26655
Dres.Klaus Josten und Ortwin Klein
Wiesbaden, 65191
Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven
Wilhelmshaven, 26389
Klinikverbund St. Antonius und St. Josef GmbH Petrus-Krankenhaus; Medi. Klinik III
Wuppertal, 42283
MVZ West GmbH Wuerselen; Haematologie-Onkologie
Würselen, 52146
Klinikum Würzburg Mitte gGmbH; Standort Missioklinik
Würzburg, 97074
Praxis Dr.med. Mathias Schulze
Zittau, 02763
About this study
Official title: The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- Atezolizumab
- 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.
AtezolizumabDrug
Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab | |
| Cohort 2 | Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
Measured: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
Duration of response (DOR) to Atezolizumab treatment
Measured: Time from first documentation of complete response (CR) or partial response (PR), whichever occurs first, until progressive disease (PD), as evaluated by the physician according to routine practice or death; through the end of study (~ 5 years)
Secondary outcomes (8)
Disease control rate (DCR) of overall population
Measured: Percentage of patients who achieved a CR, a PR, or stable disease (SD) as evaluated by the physician according to clinical practice at the time of the fifth Atezolizumab infusion; (until the end of study, approximately 5 years)
Progression-free survival (PFS) of overall population
Measured: Time from initiation of study treatment to the first occurrence of progressive disease (PD) or death from any cause, whichever occurs first, as evaluated by the physician according to clinical practice, through the end of study (approximately 5 years)
Time to response (TTR) of overall population
Measured: Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years)
Overall response rate (ORR) of overall population
Measured: Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years)
Best overall response (BOR) of overall population
Measured: Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years)
Best overall response of patients in cohort 2 ("Coh2 BOR")
Measured: Baseline through the end of study (approximately 5 years)
Overall survival of cohort 2 ("Coh2 OS")
Measured: Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).
Percentage of participants with Adverse Events (AEs)
Measured: Baseline through the end of study (approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start30 May 2018
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559647
- Sponsor's protocol ID
- ML39885
- Status last verified
- Aug 2023
- First submitted
- 7 May 2018
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reinmuth N, Gessner C, Schichtl T, Schutte W, Hammerschmidt S, Schulz H, Zortel M, Zerbes R, Reck M. Effectiveness and safety of Atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy under real-life conditions in Germany: The Non-interventional Study HYPERION. Cancer Treat Res Commun. 2025;43:100878. doi: 10.1016/j.ctarc.2025.100878. Epub 2025 Feb 10.
PubMed 40023002
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT03559647
- Acronym / sponsor ID
- ML39885
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 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.
Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab |
| Cohort 2 | – | Drug: AtezolizumabParticipants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible are participants with locally advanced or metastatic NSCLC after prior chemotherapy, who have been chosen by their treating physicians to receive atezolizumab according to the current Summary of Product Characteristics (SmPC) of TECENTRIQ
Key inclusion criteria (6 listed)
- Diagnosis of locally advanced or metastatic NSCLC (histologically or cytologically confirmed stage IIIB/stage IV) and prior chemotherapy
- Decision to be treated with Atezolizumab according to Summary of Product Characteristics (SmPC) by treating physician, independent of this non-interventional study
- No contraindication to treatment with Atezolizumab
- Participants may be included retrospectively. Retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with Atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. Quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started Atezolizumab therapy more than 9 weeks prior to ICF being obtained may not be included in the study.
- Participants who give consent to be retrospectively enrolled but have already discontinued Atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of Atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria.
Key exclusion criteria (1 listed)
- Patients not eligible for Atezolizumab treatment according to SmPC
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 |
|---|---|---|
| AtezolizumabAtezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA). | Drug | Cohort 2 |
Primary outcome
Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
Time frame: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
Duration of response (DOR) to Atezolizumab treatment
Time frame: Time from first documentation of complete response (CR) or partial response (PR), whichever occurs first, until progressive disease (PD), as evaluated by the physician according to routine practice or death; through the end of study (~ 5 years)
8 secondary outcomes
Disease control rate (DCR) of overall population
Time frame: Percentage of patients who achieved a CR, a PR, or stable disease (SD) as evaluated by the physician according to clinical practice at the time of the fifth Atezolizumab infusion; (until the end of study, approximately 5 years)
Progression-free survival (PFS) of overall population
Time frame: Time from initiation of study treatment to the first occurrence of progressive disease (PD) or death from any cause, whichever occurs first, as evaluated by the physician according to clinical practice, through the end of study (approximately 5 years)
Time to response (TTR) of overall population
Time frame: Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years)
Overall response rate (ORR) of overall population
Time frame: Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years)
Best overall response (BOR) of overall population
Time frame: Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years)
Best overall response of patients in cohort 2 ("Coh2 BOR")
Time frame: Baseline through the end of study (approximately 5 years)
Overall survival of cohort 2 ("Coh2 OS")
Time frame: Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).
Percentage of participants with Adverse Events (AEs)
Time frame: Baseline through the end of study (approximately 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 40023002Reinmuth N, Gessner C, Schichtl T, Schutte W, Hammerschmidt S, Schulz H, Zortel M, Zerbes R, Reck M. Effectiveness and safety of Atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy under real-life conditions in Germany: The Non-interventional Study HYPERION. Cancer Treat Res Commun. 2025;43:100878. doi: 10.1016/j.ctarc.2025.100878. Epub 2025 Feb 10.
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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.
Clinical Trials study director
Hoffmann-La Roche
94 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer (NSCLC), run by Hoffmann-La Roche at 94 sites in Germany.
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 6 inclusion and 1 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment (time frame: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).). The study lists 2 primary outcomes in all. 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 NCT03559647, which also lists 1 linked publication.
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 1 Sep 2023.