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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
    1d
    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)
    7d
    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)
    13d
    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)
    15d
    Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans (clinicaltrials.gov)
    P=N/A, N=76, Completed, Shandong New Time Pharmaceutical Co., LTD
    New trial
    |
    Lonsurf (trifluridine/tipiracil)
    16d
    Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study (clinicaltrials.gov)
    P1/2, N=106, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P1/2 trial • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    Avastin (bevacizumab) • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)
    18d
    BEvacizumab plus Trifluridine/tipiracil in a bi-WEEkly administration to reduce grade 3-4 Neutropenia in patients with mCRC: A prospective, multicenter, comparative, randomized GERCOR G-124 BETWEEN phase II study. (2024-520128-27-00)
    P1/2, N=162, Recruiting, Association Gercor | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation • BRAF wild-type • RAS mutation
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil)
    20d
    A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs (clinicaltrials.gov)
    P3, N=142, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Stivarga (regorafenib) • oxaliplatin • irinotecan • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil) • TQB2102
    21d
    Fruquintinib in combination with tislelizumab versus trifluridine/tipiracil and bevacizumab in third-line and beyond MSS mCRC without active liver metastases-the IKF-080/AIO-QUINTIS trial. (PubMed, ESMO Gastrointest Oncol)
    Patients with metastatic colorectal cancer (mCRC) who have progressed on fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic agents, and anti-epidermal growth factor receptor (EGFR) therapies have limited treatment options and poor prognosis, with a median overall survival (mOS) of ∼6 months on single-agent regorafenib or trifluridine/tipiracil. Tumor assessments occur every 8 weeks; follow-up continues for up to 18 months after enrolment. Optional translational research includes tumor, blood, and stool sampling to explore biomarkers of response and resistance.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • RAS mutation
    |
    Avastin (bevacizumab) • Tevimbra (tislelizumab-jsgr) • Stivarga (regorafenib) • oxaliplatin • irinotecan • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)
    28d
    Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=52, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Oct 2025
    Trial completion • Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Lonsurf (trifluridine/tipiracil)
    1m
    Effectiveness of primary tumor resection for survival after first-line cetuximab or bevacizumab in KRAS wild-type metastatic colorectal cancer treated with subsequent trifluridine/tipiracil or regorafenib. (PubMed, Ann Coloproctol)
    First-line cetuximab plus FOLFIRI may confer a survival advantage over bevacizumab in patients with KRAS wild-type mCRC without PTR, including during later-line therapy with trifluridine/tipiracil or regorafenib, whereas bevacizumab appears to provide more consistent benefits in those with PTR.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS wild-type • RAS wild-type
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • Stivarga (regorafenib) • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium
    2ms
    Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer (clinicaltrials.gov)
    P2, N=7, Suspended, M.D. Anderson Cancer Center | N=40 --> 7 | Initiation date: Nov 2025 --> Aug 2025 | Recruiting --> Suspended
    Enrollment change • Trial initiation date • Trial suspension
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil)
    2ms
    BEvacizumab plus Trifluridine/tipiracil in a bi-WEEkly administration to reduce grade 3-4 Neutropenia in patients with mCRC: A prospective, multicenter, comparative, randomized GERCOR G-124 BETWEEN phase II study. (2024-520128-27-00)
    P1/2, N=162, Not yet recruiting, Association Gercor
    New P1/2 trial
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation • BRAF wild-type • RAS mutation
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil)