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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Adult (≥ 18 years), all genders, capable of signing informed consent.
• Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.
• Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.
  • At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
  • 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.
• At least one measurable tumor lesion according to RECIST 1.1.
• ECOG score of 0 or 1.
• Adequate organ functions. Serum LDH level ≤ 2xULN.
• Life expectancy ≥ 3 months.

🚫 You may not be able to join if…

• Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
• Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
• Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
• 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.
• Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
• Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
• Active interstitial lung disease (ILD) or non-infectious pneumonitis.
• Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
• Impaired heart function.

Where this trial is running

• XCancer/Dothan Hematology & Oncology - 1114, Dothan, Alabama, United States
• Genesis Cancer and Blood Institute - 1123, Russellville, Arkansas, United States
• The Oncology Institute (TOI) Clinical Research - 1109, Cerritos, California, United States
• Emad Ibrahim MD Inc. - 1147, Redlands, California, United States
• UC Davis Comprehensive Cancer Center - 1103, Sacramento, California, United States
• Bass Medical Group - 1155, Walnut Creek, California, United States
• Nuvance Health - 1118, Norwalk, Connecticut, United States
• D&H Cancer Research Center LLC - 1153, Margate, Florida, United States
• Ocala Oncology Center PL - 1102, Ocala, Florida, United States
• AdventHealth Cancer Institute - 1105, Orlando, Florida, United States
• Orlando Health - 1130, Orlando, Florida, United States
• Florida Cancer Specialists -South - 1126, Sarasota, Florida, United States

+ 140 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05671510.