Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lonsurf · 1 trial · 3 indications
The percentage of patients without specific toxicities defined as grade 3-4-5 digestive toxicities (diarrhoea and/or stomatitis) and grade 4-5 neutropenia or febrile neutropenia over the first 2 cycles of first-line metastatic treatment. Toxicities will be graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5), widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
| Arm | Type | Description |
|---|---|---|
| Colorectal adenocarcinoma | OTHER | Trifluridine/tipiracil in association with oxaliplatin with or without: * Panitumumab in RAS wild type tumors * Bevacizumab in RAS wild type of right colon or RAS mutated tumors |
| Gastroesophageal adenocarcinoma | OTHER | Trifluridine/tipiracil in association with oxaliplatin with or without: * Trastuzumab in HER2-positive tumors (3+ IHC or 2+/FISH+) * Nivolumab if CPS≥5 and HER2-negative tumors |
| Name | Type | Description |
|---|---|---|
| Lonsurf | DRUG | Trifluridine/tipiracil orally 35 mg/m²/dose (D1-D5 twice daily, D1=D15) |
| Oxaliplatin | DRUG | Oxaliplatin intravenous injection 85 mg/m² every 2 weeks (D1=D15) |
| Panitumumab | DRUG | Panitumumab intravenous injection 6 mg/kg (D1=D15) |
| Bevacizumab | DRUG | Bevacizumab intravenous injection 5 mg/kg (D1=D15) |
| Trastuzumab | DRUG | Trastuzumab intravenous injection 4 mg/kg (D1=D15) |
| Nivolumab | DRUG | Nivolumab intravenous injection 240 mg (D1=D15) |
Inclusion Criteria: 1. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in w...
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The combination of Lonsurf and Irinotecan is being studied for use in cholangiocarcinoma and metastatic colorectal cancer. It is an investigational small molecule combination in Phase 2 clinical development, evaluated in patients with these advanced gastrointestinal cancers.
The combination of Lonsurf and Irinotecan targets cancer cells through the mechanisms of trifluridine/tipiracil and irinotecan. Trifluridine is a thymidine-based nucleoside analog that incorporates into DNA, while irinotecan inhibits topoisomerase I, together disrupting cancer cell replication.
Tango Therapeutics, Inc. (NASDAQ: TNGX) is developing the combination of Lonsurf and Irinotecan. The company is conducting clinical trials to evaluate this combination in patients with cholangiocarcinoma and metastatic colorectal cancer.
The combination of Lonsurf and Irinotecan is in Phase 2 clinical development. It is investigational and not yet approved by regulatory authorities. Two Phase 2 trials are listed, one completed and one currently recruiting participants.
The combination is studied in NCT04059562, a completed Phase 2 trial in cholangiocarcinoma, and NCT06245356, a recruiting Phase 2 trial in metastatic colorectal cancer and gastroesophageal cancer with DPD deficiency. Both are open-label, non-randomized studies.
The combination of Lonsurf and Irinotecan includes Lonsurf, which is the brand name for trifluridine/tipiracil. Lonsurf is one component of the combination, and irinotecan is added to it in the studied regimen.