NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingPhase 3

Sponsor: OncoC4, Inc.

Conditions: Non Small Cell Lung Cancer

Interventions: Gotistobart, Docetaxel

Countries: United States, Australia, Belgium, Canada, China, Germany, Italy, Netherlands

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria (Major criteria):

1. 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.

Exclusion Criteria (Major criteria):

1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
3. Receiving systemic steroid therapy with \>10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
4. 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.
5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
7. Active interstitial lung disease (ILD) or non-infectious pneumonitis.
8. Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
9. Impaired heart function.

Locations (152)

Dothan, Alabama, United States
Russellville, Arkansas, United States
Cerritos, California, United States
Redlands, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
Norwalk, Connecticut, United States
Margate, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
The Villages, Florida, United States
West Palm Beach, Florida, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Newburgh, Indiana, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
East Brunswick, New Jersey, United States
Durham, North Carolina, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Massillon, Ohio, United States
Tulsa, Oklahoma, United States
+ 122 more on CT.gov