Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gotistobart · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W | EXPERIMENTAL | Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. |
| Arm 2: Docetaxel 75 mg/m2, Q3W | ACTIVE_COMPARATOR | Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. |
| Name | Type | Description |
|---|---|---|
| Gotistobart | DRUG | Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose. |
| Docetaxel | DRUG | Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose. |
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 ...
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Gotistobart is an investigational small molecule being studied for the treatment of Non Small Cell Lung Cancer (NSCLC). It is currently in Phase 3 clinical development for patients with metastatic NSCLC that has progressed on PD-1/PD-L1 inhibitors.
Gotistobart is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 3 clinical trial to evaluate the drug in patients with Non Small Cell Lung Cancer.
Gotistobart is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, with a planned enrollment of 630 patients.
Gotistobart is being studied in a single Phase 3 clinical trial with the identifier NCT05671510. This trial compares Gotistobart to docetaxel in patients with metastatic Non Small Cell Lung Cancer that has progressed on PD-1/PD-L1 inhibitors. The trial is active but not recruiting.
Yes, Gotistobart is also known as ONC-392. The Phase 3 clinical trial NCT05671510 is titled 'ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors,' confirming that ONC-392 is the same drug as Gotistobart.