ONC-392 Versus Docetaxel for Metastatic NSCLC
This study is a Phase 3 clinical trial for people with metastatic non-small cell lung cancer (NSCLC) that has worsened after treatment with PD-1/PD-L1 inhibitor drugs. It compares a new drug called Gotistobart (ONC-392) to a standard chemotherapy drug called Docetaxel. The main goal is to see if Gotistobart can help people live longer than Docetaxel. You would receive either Gotistobart or Docetaxel through an IV infusion once every 21 days. To join, you must be at least 18 years old and have NSCLC that has progressed. The study aims to enroll about 630 participants.
- Study design
- This is a randomized, open-label Phase 3 study with two stages, comparing Gotistobart to Docetaxel. Approximately 630 patients will be enrolled.
- What's involved
- You would receive IV infusions of either Gotistobart or Docetaxel once every 21 days for up to 17 cycles, which is about one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Overall Survival (OS) will be measured at 36 months after treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
At a glance
Conditions
Where it's being run
152 sites across 57 statesStudy leadership
- Mark Socinski, MD · PRINCIPAL_INVESTIGATOR · Advent Health System
- Tianhong Li, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Davis
- Kai He, MD, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Overall Survival (OS)36 months
OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.