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.

Eligibility

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