Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab
N
Nasser Hanna, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
2
56 participants needed
4 Locations
Brief description of study
What is the purpose of this study?
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).
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the 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: NSCLC, Stage III
-
Age: 18 years - 100 years
-
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.
Updated on
28 Aug 2024.
Study ID: CTO-IUSCCC-0749, 17366
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