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    DRUG:

    Lonsurf (trifluridine/tipiracil)

    i
    Other names: TAS102, TAS-102, S 95005, FTD/TPI, S 95005/TAS-102, T15, T20, TAS 102, trifluridine AND tipiracil, T15/T20, TAS-102/S-95005, S-95005, S95005
    Company:
    Otsuka, Servier, TTY Biopharm
    Drug class:
    Thymidine phosphorylase inhibitor
    5d
    BEST: SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, Shanghai Zhongshan Hospital
    New P2 trial • Tumor mutational burden • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    6d
    Predictive factors for early mortality after regorafenib or trifluridine/tipiracil initiation in metastatic colorectal cancer. (PubMed, Oncologist)
    Our predictive model may help identify patients at high risk of early mortality after regorafenib or trifluridine/tipiracil initiation and support shared decision-making between clinicians and patients regarding further chemotherapy or best supportive care.
    Journal
    |
    CRP (C-reactive protein)
    |
    Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    6d
    KEYNOTE-A91: TATE and Pembrolizumab (MK3475) in mCRC and NSCLC (clinicaltrials.gov)
    P2, N=110, Recruiting, Teclison Ltd. | Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: Dec 2025 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    Keytruda (pembrolizumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • Tirazone (tirapazamine)
    7d
    CLARITY-Gastric 01: 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 (clinicaltrials.gov)
    P3, N=572, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    8d
    Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=170, Not yet recruiting, Gilead Sciences
    New P2 trial
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • denikitug (GS-1811)
    9d
    Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas (clinicaltrials.gov)
    P1, N=22, Recruiting, University of California, Irvine | Trial completion date: Dec 2026 --> Jan 2028 | Trial primary completion date: Dec 2025 --> Jan 2027
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    Signatera™
    |
    capecitabine • irinotecan • Lonsurf (trifluridine/tipiracil)
    9d
    A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=700, Not yet recruiting, AbbVie
    New P3 trial
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • telisotuzumab adizutecan (ABBV-400)
    13d
    Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer . (clinicaltrials.gov)
    P1/2, N=45, Recruiting, National Health Research Institutes, Taiwan | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Cyramza (ramucirumab) • Lonsurf (trifluridine/tipiracil) • Onivyde (nanoliposomal irinotecan)
    14d
    KEYNOTE-E59: A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=226, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting | N=366 --> 226 | Trial completion date: May 2028 --> Jun 2026 | Trial primary completion date: May 2028 --> Jun 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 underexpression
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • docetaxel • 5-fluorouracil • pemetrexed • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • ASP1570
    14d
    TriComB: Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients. (clinicaltrials.gov)
    P1/2, N=48, Active, not recruiting, Gruppo Oncologico Del Nord Ovest | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    Avastin (bevacizumab) • capecitabine • Lonsurf (trifluridine/tipiracil)
    20d
    Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, University of Wisconsin, Madison | Active, not recruiting --> Recruiting | N=25 --> 50 | Trial completion date: Jul 2026 --> Jul 2028 | Trial primary completion date: Jul 2026 --> Jul 2028
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 positive • RAS wild-type • RAS wild-type + HER-2 positive • HER-2 positive + RAS wild-type
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Onivyde (nanoliposomal irinotecan)
    26d
    Clinical outcomes of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil or regorafenib in metastatic colorectal cancer: a multicenter cohort study. (PubMed, ESMO Open)
    In this large real-world cohort of patients with mCRC, FTD-TPI + bevacizumab was associated with improved PFS and DCR compared with FTD-TPI or regorafenib, with consistent benefit across most molecular subgroups, including KRASG12 mutations.
    Clinical data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12
    |
    Avastin (bevacizumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)