Study name: PRESERVE-003, 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
Histology
NSCLC
Tumor stage
Stage IV
Host / recruiting sites
Antoni van Leeuwenhoek
Enrollment
Recruiting
Therapy line
Later line (≥2L)
Design
Randomized
Intervention
All enrolled patients who are randomized to the ONC-392 arm will receive ONC-392 for up to 17 cycles in approximately 1 year or until discontinuation criteria are met. Patients who are randomized to the docetaxel arm will receive docetaxel 75 mg/m2 Q3W for up to 17 cycles in approximately 1 year or until disease progression per RECIST 1.1.
Key outcome parameters
Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.
Radiographic disease progression after treatment with the most recent line of treatment being 3a or 3b as follows: a. At least 12 weeks of standard doses of PD-1/PD-L1 inhibitor in combination with platinum-containing doublet chemotherapy; b. Prior treatment with at least 2 cycles of a platinum-containing doublet 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
Key inclusion criteria
Patients who have documented non-squamous histology type or with targetable mutations or genomic alterations in the following genes: EGFR, ROS1, MET, BRAF, RET, NTRK, ALK or HER2. Patients with mutation or genomic alterations in KRAS are not excluded
Patients who have active or symptomatic brain metastases or evidence of progression within 4 weeks prior to study drug dosing. Palliative radiation or radiosurgery for brain metastases within 14 days from first day of study treatment or patients cannot achieve neurologically stable without > 10 mg daily prednisone or equivalent treatment. Patients with treated, stable brain metastases or with untreated asymptomatic brain metastases (
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