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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
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
Secondary ID [1] 0 0
2023-504308-27-00
Secondary ID [2] 0 0
1479-0008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-squamous, Non-small Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
up to 4 years and 5 months
Secondary outcome [1] 0 0
Key secondary endpoint: Overall Response (OR) according to RECIST 1.1 determined by blinded central independent review
Timepoint [1] 0 0
up to 53 months
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
Timepoint [2] 0 0
at baseline, at week 25
Secondary outcome [3] 0 0
Key secondary endpoint: Overall Survival (OS)
Timepoint [3] 0 0
up to 53 months
Secondary outcome [4] 0 0
Duration of response (DoR), determined by blinded central independent review
Timepoint [4] 0 0
up to 53 months
Secondary outcome [5] 0 0
PFS determined by blinded central independent review
Timepoint [5] 0 0
up to 53 months
Secondary outcome [6] 0 0
Bi-compartmental PFS, determined by blinded central independent review
Timepoint [6] 0 0
up to 53 months
Secondary outcome [7] 0 0
OR determined by blinded central independent review
Timepoint [7] 0 0
up to 53 months
Secondary outcome [8] 0 0
Change from baseline to Week 25 in the NSCLC-SAQ pain domain score
Timepoint [8] 0 0
at baseline, at week 25
Secondary outcome [9] 0 0
Change from baseline to Week 25 in the NSCLC-SAQ dyspnea domain score
Timepoint [9] 0 0
at baseline, at week 25
Secondary outcome [10] 0 0
Change from baseline to Week 25 in the NSCLC-SAQ cough domain score
Timepoint [10] 0 0
at baseline, at week 25
Secondary outcome [11] 0 0
Change from baseline to Week 25 in the NSCLC-SAQ appetite domain score
Timepoint [11] 0 0
at baseline, at week 25
Secondary outcome [12] 0 0
Change from baseline to Week 25 in the NSCLC-SAQ fatigue domain score
Timepoint [12] 0 0
at baseline, at week 25
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
Timepoint [13] 0 0
at baseline, at week 25
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
Timepoint [14] 0 0
up to 53 months
Secondary outcome [15] 0 0
Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0
Timepoint [15] 0 0
up to 53 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/05/2028
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital-St Leonards-20807 - St Leonards
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
Argentina
State/province [4] 0 0
Caba
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad Autónoma de Bs As
Country [6] 0 0
Argentina
State/province [6] 0 0
Córdoba
Country [7] 0 0
Argentina
State/province [7] 0 0
La Rioja
Country [8] 0 0
Argentina
State/province [8] 0 0
Mar del Plata
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Argentina
State/province [10] 0 0
Viedma
Country [11] 0 0
Austria
State/province [11] 0 0
Vienna
Country [12] 0 0
Belgium
State/province [12] 0 0
Anderlecht
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
China
State/province [18] 0 0
Chengdu
Country [19] 0 0
China
State/province [19] 0 0
Guangzhou
Country [20] 0 0
China
State/province [20] 0 0
Hangzhou
Country [21] 0 0
China
State/province [21] 0 0
Harbin
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Taizhou
Country [24] 0 0
China
State/province [24] 0 0
Tianjin
Country [25] 0 0
China
State/province [25] 0 0
Wenzhou
Country [26] 0 0
China
State/province [26] 0 0
Wuhan
Country [27] 0 0
China
State/province [27] 0 0
Zhengzhou
Country [28] 0 0
France
State/province [28] 0 0
Bron
Country [29] 0 0
France
State/province [29] 0 0
Lyon
Country [30] 0 0
France
State/province [30] 0 0
Marseille
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Villejuif
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Dresden
Country [35] 0 0
Germany
State/province [35] 0 0
Köln
Country [36] 0 0
Germany
State/province [36] 0 0
Oldenburg
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Deszk
Country [39] 0 0
Hungary
State/province [39] 0 0
Farkasgyepu
Country [40] 0 0
Hungary
State/province [40] 0 0
Szekesfehervar
Country [41] 0 0
Israel
State/province [41] 0 0
Tel Aviv
Country [42] 0 0
Italy
State/province [42] 0 0
Bari
Country [43] 0 0
Italy
State/province [43] 0 0
Catania
Country [44] 0 0
Italy
State/province [44] 0 0
Napoli
Country [45] 0 0
Italy
State/province [45] 0 0
Parma
Country [46] 0 0
Italy
State/province [46] 0 0
Varese
Country [47] 0 0
Japan
State/province [47] 0 0
Aomori, Hirosaki
Country [48] 0 0
Japan
State/province [48] 0 0
Ehime, Matsuyama
Country [49] 0 0
Japan
State/province [49] 0 0
Fukuoka, Fukuoka
Country [50] 0 0
Japan
State/province [50] 0 0
Hokkaido, Hakodate
Country [51] 0 0
Japan
State/province [51] 0 0
Hokkaido, Sapporo
Country [52] 0 0
Japan
State/province [52] 0 0
Kanagawa, Yokohama
Country [53] 0 0
Japan
State/province [53] 0 0
Miyagi, Sendai
Country [54] 0 0
Japan
State/province [54] 0 0
Okayama, Okayama
Country [55] 0 0
Japan
State/province [55] 0 0
Shizuoka, Sunto-gun
Country [56] 0 0
Japan
State/province [56] 0 0
Tokyo, Bunkyo-ku
Country [57] 0 0
Japan
State/province [57] 0 0
Tokyo, Koto-ku
Country [58] 0 0
Japan
State/province [58] 0 0
Wakayama, Wakayama
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Cheongiu
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Goyang
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seoul
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Suwon
Country [63] 0 0
Mexico
State/province [63] 0 0
Ciudad de Mexico
Country [64] 0 0
Mexico
State/province [64] 0 0
Mexico
Country [65] 0 0
Netherlands
State/province [65] 0 0
Maastricht
Country [66] 0 0
Poland
State/province [66] 0 0
Warsaw
Country [67] 0 0
Portugal
State/province [67] 0 0
Porto
Country [68] 0 0
Singapore
State/province [68] 0 0
Singapore
Country [69] 0 0
Spain
State/province [69] 0 0
Bilbao
Country [70] 0 0
Spain
State/province [70] 0 0
L'Hospitalet de Llobregat
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taichung
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taipei
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taoyuan
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Edinburgh
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


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