Screening Study for Participants With Malignant Tumors

Description

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.

Conditions

Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

Screening Study for Participants With Malignant Tumors

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Tucson

Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States, 85704

San Diego

Southern California Kaiser Permanente, San Diego, California, United States, 92108

Longmont

Rocky Mountain Cancer Centers-Penrose Pavillion, Longmont, Colorado, United States, 80504

Portland

Oregon Health Sciences Uni, Portland, Oregon, United States, 97239

Pittsburgh

Hillman Cancer Center;Medical Oncology, Pittsburgh, Pennsylvania, United States, 15232

Knoxville

Thompson Cancer Survival Center, Knoxville, Tennessee, United States, 37916-2305

Memphis

Baptist Cancer Center, Memphis, Tennessee, United States, 38120

Austin

Texas Oncology, P.A., Austin, Texas, United States, 78745

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030-4009

San Antonio

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2032-12-22