NSCLC, Stage III Clinical Trial
Official title:
Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab in Patients With Inoperable Stage III Non-small Cell Lung Cancer: The Indiana Trial
Verified date | June 2024 |
Source | Indiana University |
Contact | Ashley Vetor |
Phone | 3172742737 |
abozell[@]iu.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research aims to incorporate ctDNA analysis into clinical practice to individualize therapy in patients with stage III NSCLC by moving to a treatment-by-marker based approach (as opposed to treatment based on clinical or radiographic evidence of disease).
Status | Recruiting |
Enrollment | 56 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Age = 18 years Ability to provide written informed consent and HIPAA authorization Patients with inoperable or unresectable stage III NSCLC who are planning to receive concurrent CRT followed by consolidation Durvalumab OR Patients with inoperable or unresectable stage III NSCLC who have previously received concurrent CRT and are planning or currently receiving C1-4 consolidation durvalumab Must have viable tissue for ctDNA profiling, (fresh or archived tissue) Exclusion Criteria: Patient unwilling to provide tissue and blood samples for ctDNA testing. Patient has contraindications to treatment with concurrent CRT and/or consolidation Durvalumab. Patients with any other active cancer; excluding squamous cell or basal cell cancer. |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine if de-escalating number of Durvalumab cycles based on personalized ctDNA clearance has non-inferior 2-year PFS rate | Determine if de-escalating the number of Durvalumab cycles based on personalized ctDNA clearance guidance to at least 6 cycles after CRT in stage III non-resectable NSCLC has non-inferior 2-year PFS rate compared with historical control of empirically treating stage III non-resectable NSCLC for 1 year of Durvalumab after CRT. | Baseline to 24 months | |
Secondary | Estimate the 24-month overall survival (OS) of patient treated with consolidation Durvalumab based on personalized ctDNA clearance | Estimate the 24-month overall survival (OS) of patient treated with consolidation Durvalumab based on personalized ctDNA clearance guidance for at least 6 cycles after CRT in stage III non-resectable NSCLC. | Baseline to 24 months | |
Secondary | Estimate the 24-month PFS in patients with persistently detectable ctDNA without radiographic progression | Estimate the 24-month PFS in patients with persistently detectable ctDNA without radiographic progression of disease after receiving = 6 months of consolidation Durvalumab. | Baseline to 24 months |
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