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Recruiting
NCT06364917
DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC
Conditions: Non Small Cell Lung Cancer
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 24
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment.
Eligibility Criteria
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female aged 18 years or older.
4. Participants must have histologically or cytologically confirmed non-small cell lung cancer which is stage IV
5. Participants should not have a known sensitizing mutation for which an FDA-approved.
targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations
6. Participants should not have received prior systemic anticancer therapy for advanced or metastatic disease. For patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
7. Participants should have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
8. Participants should have a life expectancy of at least 3 months.
9. Participants should have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
10. Participants should have provided tumor tissue from locations not radiated prior to biopsy; fresh formalin fixed specimens or archival samples which have been determined as PD-L1 status \
Source: ClinicalTrials.gov (NCT06364917). StuddyBuddy aggregates publicly available trial information.