Screening Study for Participants With Malignant Tumors
- Trial number:
- NCT05419375
- Trial phase:
- 2
- Study type:
- Observational, Biomarker
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
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