Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ONO-4538 · 1 trial · 1 indication
PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| ONO-4538 group | EXPERIMENTAL | ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
| Placebo group | PLACEBO_COMPARATOR | Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| ONO-4538 | DRUG | 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
| Carboplatin | DRUG | Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
| Paclitaxel | DRUG | Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
| Bevacizumab | DRUG | Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
| Placebo | DRUG | Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. |
Inclusion Criteria: * Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer * Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification ...
Top 20 of 84 competitors
ONO-4538 is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is being evaluated in a Phase 3 clinical trial for patients with non-squamous NSCLC, a subtype of the disease. The drug is not yet approved and remains in clinical development.
ONO-4538 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied in biomarker-selected patients with non-squamous Non-Small Cell Lung Cancer, suggesting it may act on a pathway relevant to a particular genetic profile, though the exact target is not specified.
ONO-4538 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting a Phase 3 clinical trial of the drug in Non-Small Cell Lung Cancer.
ONO-4538 is in Phase 3 clinical development for Non-Small Cell Lung Cancer. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, known as TASUKI-52, has been completed.
ONO-4538 has one completed Phase 3 clinical trial, identified as NCT03117049, titled 'Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)'. The trial enrolled 550 participants in Japan, South Korea, and Taiwan, and was randomized, double-blind, and placebo-controlled.