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Screening participants with malignant tumors for eligibility in a linked clinical trial

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

PHASE2 · Hoffmann-La Roche · NCT05419375

This study is testing if certain tumor samples from people with advanced non-small cell lung cancer can help determine if they qualify for a new treatment trial.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment15000 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche (industry)
Locations155 sites (Tucson, Arizona and 154 other locations)
Trial IDNCT05419375 on ClinicalTrials.gov

What this trial studies

This study aims to assess the biomarker status of tumor tissue from participants with solid tumors to determine their eligibility for a subsequent clinical trial involving investigational medicinal products. Participants must provide a representative formalin-fixed, paraffin-embedded tumor specimen and be considered suitable candidates by the principal investigator. The focus is on individuals with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) or those requiring adjuvant treatment for specific stages of NSCLC.

Who should consider this trial

Good fit: Ideal candidates include individuals with Stage III NSCLC who have a suitable tumor specimen and meet specific performance status criteria.

Not a fit: Patients with early-stage tumors or those not meeting the inclusion criteria for NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify patients who may benefit from targeted therapies in linked clinical trials.

How similar studies have performed: Other studies have shown success in using biomarker status to guide treatment decisions in oncology, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Tucson, Arizona and 154 other locations

+105 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumors

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.