Preserve003 ONC392 vs docetaxel Prog. NSCLC after PD inhibitors (Non-Small Cell Lung Cancer)

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
For more information, contact the study team at annemarie.peters@duke.edu.

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
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.

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
ClinicalTrials.gov