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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Lerotinib is an investigational small molecule being developed for the treatment of esophageal cancer, specifically unresectable advanced or recurrent esophageal cancer. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Lerotinib is a kinase inhibitor, as indicated by its '-tinib' suffix, which means it works by inhibiting kinase enzymes involved in cancer cell signaling and growth. The specific molecular target has not been disclosed in available information.
Lerotinib is being developed by Sunshine Biopharma Inc., a company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with esophageal cancer.
Lerotinib is currently in Phase 3 clinical development. It is being studied in an active, recruiting clinical trial for unresectable advanced or recurrent esophageal cancer, with a planned enrollment of 416 participants in China.
Lerotinib is being evaluated in a Phase 3 clinical trial with the identifier NCT04415853, titled 'Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer.' The trial is recruiting patients aged 18 years and older in China and is actively enrolling participants.
Yes, Lerotinib is also known as Larotinib. The clinical trial NCT04415853 uses the name Larotinib to refer to the same drug being developed by Sunshine Biopharma for the treatment of esophageal cancer.