Phase 3 study of ONC-392 vs Docetaxel in NSCLC
Research type
Research Study
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
IRAS ID
1008733
Contact name
Hung-Yen (Peter) Chou
Contact email
Sponsor organisation
OncoC4
Clinicaltrials.gov Identifier
Research summary
The main purpose of the study is to determine whether the study drug, ONC-392, is safe and well-tolerated, and whether it is effective in treating lung cancer, in comparison with a standard of care chemotherapy drug, docetaxel. This study will enroll participants who have non-small cell lung cancer and have disease progression after platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 based immunotherapy.
ONC-392, is an investigational drug meaning it has not been approved for use as a treatment for any disease by regulatory agencies. It works by binding to a protein (CTLA-4) on immune cells inside tumours. By binding to this protein, ONC-392 acts to reduce the regulatory immune cells and let normal immune cells get into the tumour mass to fight against it. ONC-392 has been tested in early Phase 1 and Phase 2 studies since 2020. Early preliminary results suggest that it may be effective in cancer treatment.
The research study procedures include screening for eligibility and study treatment including evaluations and follow-up visits. Participants will be randomised into study drug groups or in the standard of care group. There is no placebo in this study.
Participants enrolled in Stage 1 of the study will receive one of two doses of ONC-392 or docetaxel randomly. Participants enrolled in Stage 2 of the study will receive either the ONC-392 dose selected based on information collected in Stage 1, or docetaxel. Participants will receive treatment for up to 17 cycles (approximately 1 year) and will be followed for about one to two years. It is expected that 600 people will take part in this research study globally.
This study included optional research where tumour biopsies may be performed on participants at screening and at 8 weeks after starting study treatment. However these biopsies are not mandatory for participants and they can still participate in the main study if they do not agree to have these optional biopsies.REC name
Wales REC 5
REC reference
23/WA/0267
Date of REC Opinion
8 Nov 2023
REC opinion
Further Information Favourable Opinion