Status:
RECRUITING
Screening Study for Participants With Malignant Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- General
- 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
- 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
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2032
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT05419375
Start Date
July 22 2022
End Date
December 22 2032
Last Update
January 7 2026
Active Locations (162)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85711
2
Southern California Kaiser Permanente
San Diego, California, United States, 92108
3
Rocky Mountain Cancer Centers-Penrose Pavillion
Longmont, Colorado, United States, 80504
4
Oregon Health Sciences Uni
Portland, Oregon, United States, 97239