Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plinabulin · 4 trials · 3 indications
OS is defined as the time from randomization to death from any cause
Duration of severe neutropenia (ANC \< 0.5 × 109/L)
Duration of Grade 4 neutropenia (ANC \< 0.5 × 109/L)
| Arm | Type | Description |
|---|---|---|
| Docetaxel + Plinabulin | EXPERIMENTAL | Participants will receive docetaxel IV infusion on Day 1 of each 21-day cycle plus plinabulin IV infusion on Days 1 and 8. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal, or sponsor/investigator decision. |
| Docetaxel + Placebo | PLACEBO_COMPARATOR | Participants will receive docetaxel IV infusion on Day 1 of each 21-day cycle plus matching placebo IV infusion on Days 1 and 8. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal, or sponsor/investigator decision. |
| Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin | ACTIVE_COMPARATOR | Arm 1 |
| Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim | EXPERIMENTAL | Arm 2 |
| TAC + Pegfilgrastim (6 mg) | ACTIVE_COMPARATOR | - |
| TAC + Plinabulin 10 mg/m^2 | EXPERIMENTAL | - |
| TAC + Plinabulin 20 mg/m^2 | EXPERIMENTAL | - |
| TAC + Plinabulin 30 mg/m^2 | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (1.5 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (3 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (6 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| 20 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin |
| 10 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin |
| 5 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin |
| 6 mg Pegfilgrastim | ACTIVE_COMPARATOR | 75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim |
| Name | Type | Description |
|---|---|---|
| Plinabulin | DRUG | Plinabulin will be administered by IV infusion at 30 mg/m² over approximately 1 hour on Days 1 and 8 of each 21-day treatment cycle. On Day 1, plinabulin will be administered approximately 1 hour after completion of the docetaxel infusion. |
| Docetaxel | DRUG | Docetaxel will be administered by intravenous (IV) infusion at 75 mg/m² over approximately 1 hour on Day 1 of each 21-day treatment cycle. |
| Placebo (matching plinabulin placebo) | DRUG | Matching placebo will be administered by IV infusion over approximately 1 hour on Days 1 and 8 of each 21-day treatment cycle. On Day 1, placebo will be administered approximately 1 hour after completion of the docetaxel infusion. |
| Pegfilgrastim | DRUG | PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow. |
| Saline Placebo | OTHER | Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration |
| D5W Placebo | OTHER | Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W |
| Docetaxel, doxorubicin, and cyclophosphamide (TAC) | DRUG | Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent. |
Inclusion Criteria: 1. Males and females 18 years of age or older at the time of signing the ICF 2. Willing and able to sign an ICF; 3. Non-squamous NSCLC with EGFR, ALK, ROS and RET wild type who have been diagnosed by histopathological and/or cytological examination as being ineligible for surgic...