ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncoC4, Inc.
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gotistobart
- Docetaxel
Treatment groups
630 Participants
are divided into 2 treatment groupsSponsors and collaborators
OncoC4, Inc.
Lead sponsor
BioNTech SE
Collaborator
Source ClinicalTrials.gov