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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Gotistobart (drug), Docetaxel (drug)
How long the study runs: Study runs about 62 months (dates as stated)
About the drug or intervention: Gotistobart — drug: Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose. · Docetaxel — drug: Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 630
Started: 2023-06-28
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for non small cell lung cancer
• Phase3 - 630 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with non small cell lung cancer

Where?

• Birmingham - University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
• Cambridge - Cambridge University Hospitals - 2804
• Exeter - Royal Devon University Healthcare NHS - 2808
• Leicester - University Hospital Leicester - 2806
• +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The study population consists of patients with NSCLC who progressed on PD-1/PD-L1 inhibitor. Approximately 630 patients will be enrolled. Two gotistobart dosing regimens will be tested in Stage I, and one will be selected for Stage II. Stage I, the dose-confirmation stage, will assess the efficacy and safety of two gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg Q3W) in comparison to docetaxel 75 mg/m2 Q3W. Stage II will assess the safety and efficacy of gotistobart at the selected dosing regimen versus docetaxel on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

Non Small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

PD-L1EGFRALKROS1HER2METBRAFRET

Treatment history

Treatments you must have had:

✓ at least 2 cycles of a platinum-based chemotherapy

What the study is looking for

✓Inclusion Criteria (Major criteria):
✓Adult (≥ 18 years), all genders, capable of signing agreement to take part.
✓Histologically- or cytologically- confirmed diagnosis of that has spread squamous NSCLC, metastasis can be regional lymph...
✓Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
✓At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based drug treatment;

See the full criteria

Inclusion Criteria (Major criteria): 1. Adult (≥ 18 years), all genders, capable of signing informed consent. 2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs. 3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: 1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; 2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy. Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed. 4. At least one measurable tumor lesion according to RECIST 1.1. 5. ECOG score of 0 or 1. 6. Adequate organ functions. Serum LDH level ≤ 2xULN. 7. Life expectancy ≥ 3 months. Exclusion Criteria (Major criteria): 1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy. 2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment. 3. Receiving systemic steroid therapy with \>10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment. 4. Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS mutations are not excluded. 5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug. 6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease. 7. Active interstitial lung disease (ILD) or non-infectious pneumonitis. 8. Active infections with IV antibiotics within 14 days prior to first dose of study treatment. 9. Impaired heart function.