Screening Study for Participants With Malignant Tumors | NCT05419375

Studies
Screening Study for Participants With Malignant Tumors

NCT05419375

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Feb 3, 2026Actual

Enrollment

470Actual

Phase

Phase 2

Conditions

Solid Tumors

Interventions

Screening platform

Countries

United States
Australia
Brazil
Canada
Chile
Colombia
Costa Rica
France
Germany
Hong Kong
India
Israel
Italy
Japan
Mexico
Netherlands
New Zealand
Poland
Serbia
Singapore
South Korea
Spain
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2022Actual

Primary Completion Date

Sep 3, 2025Actual

Completion Date

Sep 3, 2025Actual

First Submitted Date

Jun 13, 2022

First Submission Date that Met QC Criteria

Jun 13, 2022

First Posted Date

Jun 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 3, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

470Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Small Cell Lung Cancer (NSCLC)	Other	Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.	Other: Screening platform

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Screening platform	Other	The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.	Non-Small Cell Lung Cancer (NSCLC)

Measure	Description	Time Frame
Proportion of participants with evaluable biomarker results		Up to 10 years
Proportion of participants eligible for a linked Roche clinical trial		Up to 10 years

Eligibility Module

Eligibility Criteria

General Inclusion Criteria:

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Thompson Cancer Survival Center		Knoxville	Tennessee	37916-2305	United States
Texas Oncology, P.A.

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided