Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06151574
Registration number
NCT06151574
Ethics application status
Date submitted
22/11/2023
Date registered
30/11/2023
Titles & IDs
Public title
Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Query!
Scientific title
Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations
Query!
Secondary ID [1]
0
0
2023-504308-27-00
Query!
Secondary ID [2]
0
0
1479-0008
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-squamous, Non-small Cell
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - zongertinib
Treatment: Drugs - pembrolizumab
Treatment: Drugs - cisplatin
Treatment: Drugs - carboplatin
Treatment: Drugs - pemetrexed
Experimental: Experimental treatment arm - zongertinib only
Active comparator: Comparator arm - pembrolizumab plus platinum-pemetrexed chemotherapy
Treatment: Drugs: zongertinib
zongertinib
Treatment: Drugs: pembrolizumab
pembrolizumab
Treatment: Drugs: cisplatin
platinum-pemetrexed chemotherapy
Treatment: Drugs: carboplatin
platinum-pemetrexed chemotherapy
Treatment: Drugs: pemetrexed
platinum-pemetrexed chemotherapy
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review
Query!
Assessment method [1]
0
0
PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
Query!
Timepoint [1]
0
0
up to 4 years and 5 months
Query!
Secondary outcome [1]
0
0
Key secondary endpoint: Overall Response (OR) according to RECIST 1.1 determined by blinded central independent review
Query!
Assessment method [1]
0
0
OR is defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to RECIST 1.1 from date of randomization until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.
Query!
Timepoint [1]
0
0
up to 53 months
Query!
Secondary outcome [2]
0
0
Key secondary endpoint: Change from baseline to Week 25 of Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Query!
Assessment method [2]
0
0
The NSCLC-SAQ is a 7-item patient-reported outcome measure for use in adults to assess symptoms of advanced NSCLC.
It contains five domains and accompanying items that were identified as symptoms of NSCLC: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1).
The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms.
Query!
Timepoint [2]
0
0
at baseline, at week 25
Query!
Secondary outcome [3]
0
0
Key secondary endpoint: Overall Survival (OS)
Query!
Assessment method [3]
0
0
OS is defined as the time from randomization until death from any cause.
Query!
Timepoint [3]
0
0
up to 53 months
Query!
Secondary outcome [4]
0
0
Duration of response (DoR), determined by blinded central independent review
Query!
Assessment method [4]
0
0
DoR is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response.
Query!
Timepoint [4]
0
0
up to 53 months
Query!
Secondary outcome [5]
0
0
PFS determined by blinded central independent review
Query!
Assessment method [5]
0
0
PFS is defined as the time from randomization until tumor progression or death from any cause, whichever occurs earlier.
Query!
Timepoint [5]
0
0
up to 53 months
Query!
Secondary outcome [6]
0
0
Bi-compartmental PFS, determined by blinded central independent review
Query!
Assessment method [6]
0
0
Bi-compartmental PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
Query!
Timepoint [6]
0
0
up to 53 months
Query!
Secondary outcome [7]
0
0
OR determined by blinded central independent review
Query!
Assessment method [7]
0
0
OR is defined as best overall response of CR or PR, from date of randomization until the earliest progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.
Query!
Timepoint [7]
0
0
up to 53 months
Query!
Secondary outcome [8]
0
0
Change from baseline to Week 25 in the NSCLC-SAQ pain domain score
Query!
Assessment method [8]
0
0
The individual NSCLC-SAQ items use a five-point verbal rating scale from "No \<symptom\> At All" to "Very severe \<symptom\>" or from "Never to Always," corresponding to an (item) score of 0 to 4. A higher score indicates more severe symptoms.
Query!
Timepoint [8]
0
0
at baseline, at week 25
Query!
Secondary outcome [9]
0
0
Change from baseline to Week 25 in the NSCLC-SAQ dyspnea domain score
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
at baseline, at week 25
Query!
Secondary outcome [10]
0
0
Change from baseline to Week 25 in the NSCLC-SAQ cough domain score
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
at baseline, at week 25
Query!
Secondary outcome [11]
0
0
Change from baseline to Week 25 in the NSCLC-SAQ appetite domain score
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
at baseline, at week 25
Query!
Secondary outcome [12]
0
0
Change from baseline to Week 25 in the NSCLC-SAQ fatigue domain score
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
at baseline, at week 25
Query!
Secondary outcome [13]
0
0
Change from baseline to Week 25 in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) physical functioning domain score
Query!
Assessment method [13]
0
0
The EORTC QLQ-C30 is a quality of life questionnaire. It ranges from 0 to 100, higher scores equal worse outcome.
Query!
Timepoint [13]
0
0
at baseline, at week 25
Query!
Secondary outcome [14]
0
0
Occurrence of adverse events (AEs) during the on-treatment period, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
up to 53 months
Query!
Secondary outcome [15]
0
0
Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
up to 53 months
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
1. Signed and dated written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
2. Patients =18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
5. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor.
6. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
7. Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
Further inclusion criteria apply.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
1. Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except;
* effectively treated non-melanoma skin cancers
* effectively treated carcinoma in situ of the cervix
* effectively treated ductal carcinoma in situ
* other effectively treated malignancy that is considered cured by local treatment
2. Tumors with targetable alterations with approved available therapy.
3. Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
4. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
5. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement.
6. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
7. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of = III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
8. Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
Further exclusion criteria apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/01/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
25/05/2028
Query!
Actual
Query!
Sample size
Target
270
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [4]
0
0
St John of God Subiaco Hospital - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
6008 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Missouri
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
North Carolina
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Ohio
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
South Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Utah
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Anderlecht
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Gent
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Bento Goncalves
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Londrina
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Santo André
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Sao Paulo
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
São José do Rio Preto
Query!
Country [16]
0
0
Chile
Query!
State/province [16]
0
0
Recoleta
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Beijing
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Chengdu
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Guangzhou
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Haerbin
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Hangzhou
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Shanghai
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Taizhou
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Tianjin
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Wenzhou
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Wuhan
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Xiamen
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Zhengzhou
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Lyon
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Marseille
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Paris
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Rennes
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Strasbourg
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Villejuif
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Augsburg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Berlin
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Dresden
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Gießen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Heidelberg
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Köln
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Oldenburg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Tübingen
Query!
Country [43]
0
0
Hong Kong
Query!
State/province [43]
0
0
Hong Kong
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Haifa
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Tel Aviv
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Aichi, Nagoya
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Aomori, Hirosaki
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Ehime, Matsuyama
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Fukuoka, Fukuoka
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Hokkaido, Hakodate
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Hokkaido, Sapporo
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Ishikawa, Kanazawa
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Kanagawa, Kawasaki
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Kanagawa, Yokohama
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Kyoto, Kyoto
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Miyagi, Sendai
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Okayama, Okayama
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Osaka, Osaka
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Shizuoka, Sunto-gun
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Tokyo, Bunkyo-ku
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Tokyo, Koto-ku
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Wakayama, Wakayama
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Cheongiu
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Goyang
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Incheon
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Seoul
Query!
Country [67]
0
0
Korea, Republic of
Query!
State/province [67]
0
0
Suwon
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Ciudad de Mexico
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Mexico
Query!
Country [70]
0
0
Netherlands
Query!
State/province [70]
0
0
Maastricht
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Lodz
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Poznan
Query!
Country [73]
0
0
Portugal
Query!
State/province [73]
0
0
Lisboa
Query!
Country [74]
0
0
Portugal
Query!
State/province [74]
0
0
Porto
Query!
Country [75]
0
0
Singapore
Query!
State/province [75]
0
0
Singapore
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Alicante
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Barcelona
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Bilbao
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
L'Hospitalet de Llobregat
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Madrid
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Málaga
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Sevilla
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Valencia
Query!
Country [84]
0
0
Sweden
Query!
State/province [84]
0
0
Göteborg
Query!
Country [85]
0
0
Sweden
Query!
State/province [85]
0
0
Stockholm
Query!
Country [86]
0
0
Taiwan
Query!
State/province [86]
0
0
Taichung
Query!
Country [87]
0
0
Taiwan
Query!
State/province [87]
0
0
Taoyuan
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
London
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06151574
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-800-243-0127
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Query!
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06151574