At a glance
ClinicalIndex Comparison Record- ✓Adult age ≥18 years, all genders
- ✓Histologically or cytologically confirmed metastatic squamous NSCLC
- ✓Radiographic progression after ≥12 weeks PD-1/PD-L1 inhibitor-based treatment
- ✓At least one measurable tumor lesion per RECIST 1.1
- ✕Cancer treatment-related AEs not recovered to grade ≤1 (except endocrinopathy)
- ✕Last anti-PD-1/PD-L1 dosing within 28 days prior to first study dose
- ✕Systemic steroid therapy >10 mg/day prednisone or equivalent within 7 days before first dose
- ✕Actionable mutations in EGFR, ALK, ROS1, HER2, MET, BRAF, RET, or NTRK (KRAS mutations allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors
In Brief
A Phase 3 clinical trial evaluating Gotistobart and Docetaxel for Non Small Cell Lung Cancer. Currently recruiting, targeting 630 participants across 152 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.
Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.