Screening Study for Participants With Malignant Tumors

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05419375

Collaborator

(none)

15,000

Enrollment

Locations

Arm

121.1

Anticipated Duration (Months)

1363.6

Patients Per Site

11.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Other: Screening platform	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors

Actual Study Start Date :

Jul 22, 2022

Anticipated Primary Completion Date :

Aug 21, 2032

Anticipated Study Completion Date :

Aug 23, 2032

Arms and Interventions

Arm	Intervention/Treatment
Other: Non-Small Cell Lung Cancer (NSCLC) Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.	Other: Screening platform The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.

Arm

Intervention/Treatment

Other: Non-Small Cell Lung Cancer (NSCLC)

Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.

Other: Screening platform

The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85704
2	Rocky Mountain Cancer Centers-Penrose Pavillion	Colorado Springs	Colorado	United States	80907
3	Texas Oncology, P.A.	Austin	Texas	United States	78745
4	Texas Oncology, P.A.	San Antonio	Texas	United States	78229
5	Texas Oncology, P.A. - Tyler; Tyler Cancer Center	Tyler	Texas	United States	75702
6	Oncology & Hematology Associates of Southwest Virginia, Inc	Blacksburg	Virginia	United States	24060
7	Northwest Cancer Specialists	Vancouver	Washington	United States	98686
8	Clinica CIMCA	San José		Costa Rica	10103
9	ICIMED Instituto de Investigación en Ciencias Médicas	San José		Costa Rica	10108
10	Sendai Kousei Hospital	Miyagi		Japan	980-0873
11	Korea University Guro Hospital	Seoul		Korea, Republic of	08308

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT05419375

Other Study ID Numbers:

BX43361

First Posted:

Jun 15, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Aug 11, 2022