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Clinical trialNCT05671510Active, not recruitingPhase 3Interventional

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

SponsorOncoC4, Inc.Enrollment630Non Small Cell Lung Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this Phase 3 clinical trial is to 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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

152 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Bankstown Hospital - 3305

    Bankstown, New South Wales, Australia

  • Mater - 3301

    Newstead, Queensland, Australia

  • Cancer Research Sa - 3303

    Adelaide, South Australia, Australia

  • Western Health - Sunshine Hospital - 3307

    St Albans, Victoria, Australia

Belgium
  • Az Maria Middelares - 2104

    Ghent, Belgium

  • Jessa Ziekenhuis (jessa Hospital) - Campus Salvator - 2102

    Hasselt, Belgium

  • C. H. R. de la Citadelle - 2103

    Liège, Belgium

  • Vitaz - Sint-Niklaas Moerland - 2101

    Sint-Niklaas, Belgium

Canada
  • Bc Cancer Centre - Kelowna - 1203

    Kelowna, British Columbia, Canada

  • Saskatchewan Cancer Agency - Regina - 1201

    Regina, Saskatchewan, Canada

  • Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202

    Saskatoon, Saskatchewan, Canada

China
  • Anhui Medical University - the Second Hospital - 3222

    Hefei, Anhui, China

  • the First Affiliated Hospital of Anhui Medical University - 3221

    Hefei, Anhui, China

  • Beijing Cancer Hospital - 3205

    Beijing, Beijing Municipality, China

  • Cancer Hospital, Chinese Academy of Medical Sciences - 3211

    Beijing, Beijing Municipality, China

  • Fujian Medical University Union Hospital - 3225

    Fuzhou, Fujian, China

  • the First Affiliated Hospital of Xiamen University - 3210

    Xiamen, Fujian, China

  • Dongguan People'S Hospital - 3206

    Dongguan, Guangdong, China

  • Guangdong Provincial People'S Hospital - 3201

    Guangzhou, Guangdong, China

  • the First Affiliated Hospital of Guangdong Pharmaceutical University - 3215

    Guangzhou, Guangdong, China

  • Zhujiang Hospital of Southern Medical University - 3203

    Guangzhou, Guangdong, China

  • the People'S Hospital of Guangxi Zhuang Autonomous Region - 3228

    Nanning, Guangxi, China

  • Hainan General Hospital - 3202

    Haikou, Hainan, China

  • Affiliated Hospital of Hebei University - 3214

    Zhengzhou, Hebei, China

  • the Affiliated Tumor Hospital of Harbin Medical University - 3232

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital - 3226

    Zhengzhou, Henan, China

  • the First Affliated Hospital of Zhengzhou University - 3207

    Zhengzhou, Henan, China

  • Renmin Hospital of Wuhan University - 3216

    Wuhan, Hubei, China

  • Union Hospital Tongji Medical College - 3212

    Wuhan, Hubei, China

  • Hunan Cancer Hospital - 3209

    Changsha, Hunan, China

  • Xiangya Hospital, Central South University - 3223

    Changsha, Hunan, China

  • the Second Affiliated Hospital of Soochow University - 3217

    Suzhou, Jiangsu, China

  • Xuzhou Medical University - the Affiliated Hospital - 3234

    Xuzhou, Jiangsu, China

  • the Second Affiliated Hospital of Nanchang University - 3224

    Nanchang, Jiangxi, China

  • Jinan Central Hospital - 3230

    Jinan, Shandong, China

  • Shanxi Bethune Hospital - 3233

    Taiyuan, Shanxi, China

  • the First Affiliated Hospital of Xi'An Jiaotong University - 3218

    Xi’an, Shanxi, China

  • Chengdu Seventh People'S Hospital - 3229

    Chengdu, Sichuan, China

  • Sichuan Cancer Hospital - 3227

    Chengdu, Sichuan, China

  • Chongqing University Cancer Hospital - 3213

    Chongqing, Sichuan, China

112 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Docetaxel →Gotistobart
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Jun 2023
Primary completion
31 Aug 2027
Completion
31 Aug 2028
Last update posted
13 Aug 2026
Registered enrollment
630
Registry id
NCT05671510

Cross-registrations

EU-CTR / CTIS (EudraCT)2023-505311-20-01
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.