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Preserve003 ONC392 vs docetaxel Prog. NSCLC after PD inhibitors (Non-Small Cell Lung Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find the most effective, safe dose of an experimental drug called ONC-392 (the study drug). We want to know how well it works compared to the standard chemotherapy drug, docetaxel, for treating NSCLC.
What is the Condition Being Studied?
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with metastatic NSCLC
- Have metastases to regional lymph nodes or distant organs
- Had their disease progress after treatment
- Do not have metastases to the brain
- Do not have documented targetable mutations or genomic alterations in the following genes: EGFR, ROS1, MET, BRAF, RET, NTRK, ALK, or HER2
For more information, contact the study team at annemarie.peters@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups. You will either:
- Get the study drug while you take part in the study; OR
- Get the standard treatment for your diagnosis, doetaxel
Both the study drug and standard treatment are given as intravenous (IV) infusions. No matter to which group you are assigned, you will get a drug infusion every 3 weeks. You will receive up to 17 infusions.
Study Details
Full Title
Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors. ((PRESERVE-003))
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00116554
NCT:
NCT05671510
Phase
Phase
III
ClinicalTrials.gov
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Enrollment Status
Open for Enrollment Soon