NCT05671510 · OncoC4, Inc.
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
(PRESERVE-003)
What this study is about
The goal of this Phase 3 clinical trial is study the safety and effectiveness 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.
View original scientific description
The goal of this Phase 3 clinical trial is 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.
Interventions
DRUG
Gotistobart
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.
DRUG
Docetaxel
Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.
Primary outcome measures
Overall Survival (OS)
Time frame: 36 months
OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 n
Where
- Dothan, Alabama
- Russellville, Arkansas
- Cerritos, California
- Redlands, California
- Sacramento, California
- Walnut Creek, California
- Norwalk, Connecticut
- Margate, Florida
- Ocala, Florida
- Orlando, Florida
- Sarasota, Florida
- The Villages, Florida
And 33 more locations — see the full list below.
Collaborators
BioNTech SE
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations