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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Principal Investigator
Eziafa
Oduah
Protocol Number
PRO00116554
NCT ID
NCT05671510
Phase
III
Enrollment Status
Pending Open to Enrollment