Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab
Investigating the Use of a Blood Test for Cancer Markers in Advanced Lung Cancer Treatment
Nasser Hanna, MD
Primary Investigator
Brief description of study
Detailed description of study
- Experimental: Consolidation to Durvalumab
- All subjects will receive consolidation Durvalumab approximately every 4 weeks. Prior to the 5th cycle the first mandatory ctDNA test will be done.
- If it's negative and the subsequent test 4 weeks later prior to cycle 6 is negative, then Durvalumab will be stopped otherwise subject will continue consolidation durvalumab until 2 negative ctDNA analyses performed approximately 4 weeks apart or up to 1 year of consolidation per standard medical practice is complete.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non-small Cell Lung Cancer
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Age: 18 years - 100 years
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Gender: All
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.
This study investigates the use of circulating tumor DNA (ctDNA) to personalize treatment for patients with stage III non-small cell lung cancer (NSCLC). The purpose is to use ctDNA analysis to guide therapy decisions, instead of relying solely on clinical or radiographic evidence of disease. This approach aims to tailor treatment based on specific markers found in the blood.
Participants in the study will receive a medication called Durvalumab every four weeks. Before the fifth cycle, a ctDNA test is required. If the test is negative, and another test four weeks later is also negative, the medication will be stopped. If not, treatment continues until two negative tests are obtained or up to one year. ctDNA is a type of blood test that looks for cancer markers.
- Who can participate: Adults aged 18 and older with inoperable or unresectable stage III NSCLC who are planning to receive or are currently receiving specific treatments may be eligible. Participants must be able to provide consent and have tissue available for ctDNA profiling.
- Study details: Participants will receive Durvalumab every four weeks. A ctDNA test will be conducted before the fifth cycle. If the test is negative and a subsequent test is also negative, Durvalumab will be stopped. Otherwise, treatment continues until two negative tests are obtained or up to one year.
- Study timelines: The study will last up to 1 year.
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