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Gotistobart / Non Small Cell Lung Cancer / Docetaxel · Phase 3 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized trial comparing gotistobart (ONC-392), a next-generation anti-CTLA-4 antibody, to docetaxel in patients with metastatic NSCLC resistant to PD-1/PD-L1 inhibitors, with overall survival over 36 months as the primary endpoint. No efficacy, safety, or outcome data are reported in this registry record; the trial is active but recruitment is closed, and results remain pending.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non Small Cell Lung Cancer; age from 18 Years. Intervention: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg…. Compared with: Arm 2: Docetaxel 75 mg/m2, Q3W — Active Comparator. n = 630. 152 sites across 12 countries.
This is a Phase 3 randomized trial comparing gotistobart (ONC-392), a next-generation anti-CTLA-4 antibody, to docetaxel in patients with metastatic NSCLC resistant to PD-1/PD-L1 inhibitors, with overall survival over 36 months as the primary endpoint. No efficacy, safety, or outcome data are reported in this registry record; the trial is active but recruitment is closed, and results remain pending.
No efficacy, safety, or outcome results are reported in this registry record.
Clinicians should monitor for publication of results from this trial, which will directly address whether anti-CTLA-4 checkpoint inhibition (gotistobart) can improve survival in PD-1/PD-L1–refractory metastatic NSCLC compared to standard docetaxel chemotherapy.
This is a Phase 3 trial registration with no posted results; the study is active but not recruiting, and efficacy and safety outcomes have not yet been reported.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should monitor for publication of results from this trial, which will directly address whether anti-CTLA-4 checkpoint inhibition (gotistobart) can improve survival in PD-1/PD-L1–refractory metastatic NSCLC compared to standard docetaxel chemotherapy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05671510). This is a study registration, not published results. Lead sponsor: OncoC4, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 630 participants (ESTIMATED). Conditions: Non Small Cell Lung Cancer. Interventions: DRUG: Gotistobart; DRUG: Docetaxel. Primary outcome measures: Overall Survival (OS) , 36 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.