ClinicaliQ Trial Snapshot
- ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors — Recruiting • Phase III • Oncology • NCT05671510.
- What is being tested: ONC-392 (gotistobart), a next-generation anti-CTLA-4 antibody, is being compared against standard docetaxel chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) that has progressed despite prior PD-1/PD-L1 inhibitor treatment.
- Patient eligibility overview: The trial includes patients with metastatic NSCLC who have experienced disease progression on anti-PD-1/PD-L1 checkpoint inhibitor therapy, representing a population with limited effective treatment options and poor prognosis.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- (Major criteria):
- 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.