Screening Study for Participants With Malignant Tumors

Trial number:
NCT05419375
Trial phase:
2
Study type:
Observational, Biomarker
Overall status:
Recruiting

Study start date

July, 2022

Scientific title

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

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.

General

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 trial

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 systemEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

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

Study design

Primary purpose: Other, Allocation: N/A, Intervention model: Single Group Assignment, Masking: None (Open Label),

Conditions

Solid Tumors

Other study ID numbers

BX43361

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