Therapy Detail

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Therapy Name Trifluridine-tipiracil hydrochloride
Synonyms
Therapy Description

Lonsurf (trifluridine/tipiracil hydrochloride) is an oral combination comprised of TFT and a thymidine phosphorylase inhibitor, which can result in DNA fragmentation thereby preventing angiogenesis and tumor growth (PMID: 29226002). Lonsurf (trifluridine/tipiracil hydrochloride) is FDA-approved for use in patients with colorectal cancer, gastric or gastroesophageal junction adenocarcinoma, and in combination with Avastin (bevacizumab) in patients with previously-treated metastatic colorectal cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Trifluridine-tipiracil hydrochloride Lonsurf TAS-102|TAS102|TAS 102|S 95005|S95005|S-95005 Lonsurf (trifluridine/tipiracil hydrochloride) is an oral combination comprised of TFT and a thymidine phosphorylase inhibitor, which can result in DNA fragmentation thereby preventing angiogenesis and tumor growth (PMID: 29226002). Lonsurf (trifluridine/tipiracil hydrochloride) is FDA-approved for use in patients with colorectal cancer, gastric or gastroesophageal junction adenocarcinoma, and in combination with Avastin (bevacizumab) in patients with previously-treated metastatic colorectal cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04489173 Phase II Trifluridine-tipiracil hydrochloride TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer (TIBET) Active, not recruiting NLD 0
NCT03520946 Phase III Ramucirumab + Trifluridine-tipiracil hydrochloride Trifluridine-tipiracil hydrochloride RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients (RAMTAS) Completed DEU 0
NCT02301117 Phase I Trifluridine-tipiracil hydrochloride A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment Completed USA | CZE 1
NCT02602327 Phase I Trifluridine-tipiracil hydrochloride Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases Completed USA 0
NCT04854434 Phase II Trifluridine-tipiracil hydrochloride Pembrolizumab + Selinexor Selinexor A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations Terminated USA 0
NCT04776148 Phase III Regorafenib Trifluridine-tipiracil hydrochloride Lenvatinib + Pembrolizumab Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017) Completed USA | TUR | ISR | GBR | ESP | DNK | DEU | CAN | AUS | ARG 5
NCT03844620 Phase II Regorafenib Trifluridine-tipiracil hydrochloride Regorafenib + Trifluridine-tipiracil hydrochloride Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer Active, not recruiting USA 0
NCT04073615 Phase Ib/II Rivoceranib + Trifluridine-tipiracil hydrochloride Rivoceranib Trifluridine-tipiracil hydrochloride Phase 1b/2 Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer Terminated USA 0
NCT05062889 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (ERASE-CRC) Recruiting ITA 0
NCT03981614 Phase II Trifluridine-tipiracil hydrochloride Binimetinib + Palbociclib Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Completed USA 0
NCT01916447 Phase I Bevacizumab Trifluridine-tipiracil hydrochloride Irinotecan A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors. Completed USA 0
NCT01607957 Phase III Trifluridine-tipiracil hydrochloride Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies (RECOURSE) Completed USA | SWE | ITA | IRL | GBR | FRA | ESP | DEU | CZE | BEL | AUT | AUS 1
NCT06356311 Phase III Trifluridine-tipiracil hydrochloride Irinotecan Paclitaxel Docetaxel SKB264 A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) Recruiting USA | POL | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL 8
NCT04042714 Phase II Trifluridine-tipiracil hydrochloride TAS-102 in Extrapulmonary Neuroendocrine Carcinoma (TAS-102 NEC) Unknown status USA 0
NCT03762161 Phase II Trifluridine-tipiracil hydrochloride A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer Unknown status USA 0
NCT05223673 Phase III Trifluridine-tipiracil hydrochloride Futuximab + Modotuximab Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer (COLSTAR) Terminated USA | HUN | FIN | DNK | BEL 1
NCT04737187 Phase III Bevacizumab + Trifluridine-tipiracil hydrochloride Trifluridine-tipiracil hydrochloride Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT) Completed USA | POL | ITA | HUN | FRA | ESP | DNK | DEU | BRA | BEL | AUT 3
NCT04879368 Phase III Docetaxel Paclitaxel Trifluridine-tipiracil hydrochloride Nivolumab + Regorafenib Irinotecan RegoNivo vs Standard of Care Chemotherapy in AGOC (INTEGRATEIIb) Active, not recruiting USA | ITA | ESP | DEU | AUT | AUS 3
NCT05201352 Phase Ib/II Trifluridine-tipiracil hydrochloride Trifluridine-tipiracil hydrochloride + XB2001 Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1alpha True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine (TASKIN) Recruiting FRA 0
NCT06346392 Phase III Rivoceranib Trifluridine-tipiracil hydrochloride Paclitaxel + Ramucirumab Docetaxel Paclitaxel Irinotecan AZD0901 AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 Recruiting USA | POL | ITA | GBR | FRA | ESP | DEU | CHE | CAN 7
NCT02500043 Phase III Trifluridine-tipiracil hydrochloride Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer Completed USA | TUR | ROU | POL | ITA | ISR | IRL | GBR | FRA | ESP | DEU | CZE | CAN | BEL 4
NCT03992456 Phase II Panitumumab Regorafenib Trifluridine-tipiracil hydrochloride Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer Active, not recruiting USA 0


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