Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT05419375




Registration number
NCT05419375
Ethics application status
Date submitted
13/06/2022
Date registered
15/06/2022
Date last updated
18/11/2024

Titles & IDs
Public title
Screening Study for Participants With Malignant Tumors
Scientific title
Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors
Secondary ID [1] 0 0
BX43361
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Screening platform

Other: Non-Small Cell Lung Cancer (NSCLC) - Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.


Other interventions: Screening platform
The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with evaluable biomarker results
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
Proportion of participants eligible for a linked Roche clinical trial
Timepoint [2] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
General

* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
* Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial

Inclusion Criteria for Participants with Stage III NSCLC

* Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment

* Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
* Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
* Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
* Representative FFPE tumor specimen obtained prior to the start of any treatment
* ECOG Performance Status of 0 or 1

General
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
* Any condition that may affect the interpretation of study results
* Significant liver or cardiovascular disease
* Prior allogenic stem-cell or solid-organ transplantation

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
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
22/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/12/2032
Actual
Sample size
Target
15000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Lifehouse - Camperdown
Recruitment hospital [2] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [3] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [5] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Belgium
State/province [10] 0 0
Charleroi
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Brazil
State/province [12] 0 0
BA
Country [13] 0 0
Brazil
State/province [13] 0 0
CE
Country [14] 0 0
Brazil
State/province [14] 0 0
MG
Country [15] 0 0
Brazil
State/province [15] 0 0
RJ
Country [16] 0 0
Brazil
State/province [16] 0 0
RS
Country [17] 0 0
Brazil
State/province [17] 0 0
SC
Country [18] 0 0
Brazil
State/province [18] 0 0
SP
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
Country [21] 0 0
Chile
State/province [21] 0 0
Temuco
Country [22] 0 0
Colombia
State/province [22] 0 0
Barranquilla
Country [23] 0 0
Colombia
State/province [23] 0 0
Bogota, D.C.
Country [24] 0 0
Colombia
State/province [24] 0 0
Bogota
Country [25] 0 0
Colombia
State/province [25] 0 0
Medellin
Country [26] 0 0
Costa Rica
State/province [26] 0 0
San José
Country [27] 0 0
France
State/province [27] 0 0
Toulouse
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
Country [29] 0 0
Hong Kong
State/province [29] 0 0
Hong Kong
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Petach Tikva
Country [32] 0 0
Italy
State/province [32] 0 0
Emilia-Romagna
Country [33] 0 0
Italy
State/province [33] 0 0
Lazio
Country [34] 0 0
Italy
State/province [34] 0 0
Liguria
Country [35] 0 0
Italy
State/province [35] 0 0
Lombardia
Country [36] 0 0
Italy
State/province [36] 0 0
Piemonte
Country [37] 0 0
Italy
State/province [37] 0 0
Puglia
Country [38] 0 0
Italy
State/province [38] 0 0
Toscana
Country [39] 0 0
Italy
State/province [39] 0 0
Veneto
Country [40] 0 0
Japan
State/province [40] 0 0
Aichi
Country [41] 0 0
Japan
State/province [41] 0 0
Aomori
Country [42] 0 0
Japan
State/province [42] 0 0
Ehime
Country [43] 0 0
Japan
State/province [43] 0 0
Fukuoka
Country [44] 0 0
Japan
State/province [44] 0 0
Hyogo
Country [45] 0 0
Japan
State/province [45] 0 0
Kagoshima
Country [46] 0 0
Japan
State/province [46] 0 0
Kanagawa
Country [47] 0 0
Japan
State/province [47] 0 0
Kumamoto
Country [48] 0 0
Japan
State/province [48] 0 0
Miyagi
Country [49] 0 0
Japan
State/province [49] 0 0
Nara
Country [50] 0 0
Japan
State/province [50] 0 0
Niigata
Country [51] 0 0
Japan
State/province [51] 0 0
Okayama
Country [52] 0 0
Japan
State/province [52] 0 0
Osaka-sayama
Country [53] 0 0
Japan
State/province [53] 0 0
Osaka
Country [54] 0 0
Japan
State/province [54] 0 0
Shizuoka
Country [55] 0 0
Japan
State/province [55] 0 0
Tokyo
Country [56] 0 0
Japan
State/province [56] 0 0
Tottori
Country [57] 0 0
Japan
State/province [57] 0 0
Yamaguchi
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Cheongju-si
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Daegu
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Gyeongsangnam-do
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Jeollanam-do
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seongnam-si
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Netherlands
State/province [64] 0 0
Maastricht
Country [65] 0 0
New Zealand
State/province [65] 0 0
Auckland
Country [66] 0 0
Norway
State/province [66] 0 0
Oslo
Country [67] 0 0
Poland
State/province [67] 0 0
Gdansk
Country [68] 0 0
Poland
State/province [68] 0 0
Lublin
Country [69] 0 0
Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Poland
State/province [70] 0 0
Wroc?aw
Country [71] 0 0
Serbia
State/province [71] 0 0
Belgrade
Country [72] 0 0
Serbia
State/province [72] 0 0
Kragujevac
Country [73] 0 0
Serbia
State/province [73] 0 0
Sremska Kamenica
Country [74] 0 0
Singapore
State/province [74] 0 0
Singapore
Country [75] 0 0
Spain
State/province [75] 0 0
LAS Palmas
Country [76] 0 0
Spain
State/province [76] 0 0
Alicante
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Malaga
Country [79] 0 0
Spain
State/province [79] 0 0
Sevilla
Country [80] 0 0
Taiwan
State/province [80] 0 0
New Taipei City
Country [81] 0 0
Taiwan
State/province [81] 0 0
Tainan
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taipei City
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taoyuan
Country [85] 0 0
Taiwan
State/province [85] 0 0
Xitun Dist.
Country [86] 0 0
Thailand
State/province [86] 0 0
Bangkok
Country [87] 0 0
Thailand
State/province [87] 0 0
Dusit
Country [88] 0 0
Thailand
State/province [88] 0 0
Nonthaburi
Country [89] 0 0
Thailand
State/province [89] 0 0
Songkhla
Country [90] 0 0
Turkey
State/province [90] 0 0
Adana
Country [91] 0 0
Turkey
State/province [91] 0 0
Ankara
Country [92] 0 0
Turkey
State/province [92] 0 0
Bakirkoy / Istanbul
Country [93] 0 0
Turkey
State/province [93] 0 0
Erzurum
Country [94] 0 0
Turkey
State/province [94] 0 0
Istanbul
Country [95] 0 0
Turkey
State/province [95] 0 0
Samsun
Country [96] 0 0
Turkey
State/province [96] 0 0
Seyhan
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.
Trial website
https://clinicaltrials.gov/study/NCT05419375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BX43361 https://forpatients.roche.com
Address 0 0
Country 0 0
Phone 0 0
1-888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05419375