Solid Tumors
Conditions
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.
Interventions
OTHERScreening platform
The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | 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 |
Countries
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, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed