UT Health San Antonio

Screening Study for Participants With Malignant Tumors

Purpose

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

Solid Tumors

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

Mays Cancer Center, UT Health San Antonio
San Antonio, Texas 78229-4427

More Details

Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: BX43361 https://forpatients.roche.com
1-888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.