Last updated 5 days ago
Screening Study for Participants With Malignant Tumors
15000 patients around the world
Available in Colombia, Brazil, Chile, United States, Costa Rica
Hoffmann-La Roche
9Research sites
15000Patients around the world
This study is for people with
Advanced tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocolConsidered 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 trialLocally 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 systemEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2Stage 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 protocolRepresentative FFPE tumor specimen obtained prior to the start of any treatmentECOG 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 deathAny condition that may affect the interpretation of study resultsSignificant liver or cardiovascular diseasePrior allogenic stem-cell or solid-organ transplantation
Sites
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
Orlandi Oncología
Recruiting
James Lind Centro de Investigación del Cáncer - Temuco
Recruiting
Hospital Universitario San Ignacio - Bogotá
Recruiting
Instituto de Cancerología Las Américas
Recruiting
ICIMED Instituto de Investigación en Ciencias Médicas
Recruiting
Clínica CIMCA
Recruiting
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Advanced tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05419375
