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Compares treatment options for Non Small Cell Lung Cancer
Official title ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
ClinicalTrials.gov ID: NCT05671510
What this study is testing
What is Gotistobart?
Gotistobart is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Also referred to as A humanized anti-CTLA4 IgG1 monoclonal antibody, ONC-392.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (Major criteria):
- 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;
You likely can't join if
- (Major criteria):
- 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...
- Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study...
See the full eligibility criteria
- (Major criteria):
- 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...
- 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.
- (Major criteria):
- 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.
- Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
- Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
- Active interstitial lung disease (ILD) or non-infectious pneumonitis.
- Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
- Impaired heart function.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- 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
+ 112 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 126 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.