Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lerotinib · 1 trial · 1 indication
Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.
| Arm | Type | Description |
|---|---|---|
| Lerotinib Arm | EXPERIMENTAL | 350 mg,qd, orally about half an hour after a meal, continuous administration, every 21 days for a treatment cycle. |
| Active Comparator Arm | ACTIVE_COMPARATOR | Irinotecan: Intravenously administered at a dose of 180 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Tegafur: 40-60mg po bid(d1-d14),every 21 days as a cycle, continuous drug administration from 1 to 14 days of each cycle, and then stopped 7 days. |
| Name | Type | Description |
|---|---|---|
| Lerotinib | DRUG | Specification: 50 mg/capsule and 150 mg/capsule |
| Irinotecan/Tegafur | DRUG | Irinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule |
Inclusion Criteria: 1. Age:18-75 years, male or female. 2. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus or advanced/metastatic disease. 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of greater than 3 months...
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