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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Pan Zheng, MD, PhD 2027516823
pzheng@oncoc4.com


Study Location:

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Be Part of Research - Trial Details - ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Lung Neoplasms
Carcinoma, Non-Small-Cell Lung


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2023 Jun 2026

Publications

"Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2."; "31267017"; "Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10."; "31836191"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.

Intervention Arm Group : Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W;Arm 2: Gotistobart 3 mg/kg Q3W;

Intervention Type : DRUG
Intervention Description : Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.

Intervention Arm Group : Arm 3: Docetaxel 75 mg/m2, Q3W;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
    Birmingham
    England
    B15 2TG
  • Cambridge University Hospitals - 2804
    Cambridge
    England
    CB2 0QQ
  • University Hospital Leicester - 2806
    Leicester
    England
    LE1 5WW
  • The Christie NHS Foundation Trust - 2803
    London
    England
    EC1A 7BE
  • Barts Health NHS Trust (St. Bartholomew's Hospital) - 2802
    Manchester
    England
    M20 4BX
  • Torbay Hospital - Horizon Centre - 2805
    Torquay
    England
    TQ2 7AA
  • Royal Devon University Healthcare NHS - 2808
    Exeter
    England
    EX25DW
  • South Tees Hospitals - 2807
    Middlesbrough
    England
    TS4 3BW
  • University Hospital Southampton - 2810
    Southampton
    England
    SO16 6YD
  • Edinburgh Cancer Centre - 2809
    Edinburgh
    Scotland
    EH4 2XU

Pan Zheng, MD, PhD 2027516823
pzheng@oncoc4.com



The study is sponsored by OncoC4, Inc. and is in collaboration with BioNTech SE.




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Read full details for Trial ID: NCT05671510
Last updated 20 February 2025

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