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

Prior treatment

• 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.
• Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
• Active infections with IV antibiotics within 14 days prior to first dose of study treatment.

Other illness

• Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
• Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
• Active interstitial lung disease (ILD) or non-infectious pneumonitis.
• Impaired heart function.

Lab values

• 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.

• 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:
  • 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.
  • Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.
• 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.