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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
    14d
    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=592, 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)
    19d
    TIBET: TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=52, Completed, Borstkanker Onderzoek Groep | Active, not recruiting --> Completed | Trial completion date: Nov 2025 --> May 2026
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Lonsurf (trifluridine/tipiracil)
    19d
    Matching-Adjusted Indirect Comparison of Sotorasib Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab in Chemorefractory Metastatic Colorectal Cancer. (PubMed, Clin Colorectal Cancer)
    In this MAIC analysis, soto960+pani demonstrated statistically significant improvement in response rates and OS in patients with chemorefractory KRAS G12C-mutated mCRC.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Avastin (bevacizumab) • Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    19d
    Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas (clinicaltrials.gov)
    P1, N=411, Recruiting, Inhibrx Biosciences, Inc | Trial completion date: Dec 2026 --> Jun 2029 | Trial primary completion date: Jun 2026 --> Dec 2028
    Trial completion date • Trial primary completion date • First-in-human
    |
    Avastin (bevacizumab) • carboplatin • 5-fluorouracil • temozolomide • pemetrexed • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • ozekibart (INBRX-109)
    20d
    Feasibility Study of Trifluridine/Tipiracil and Zolbetuximab as Third- or Later-Line Chemotherapy for CLDN18.2-Positive and HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma: A Study Protocol. (PubMed, Cancer Med)
    Zolbetuximab is an anti-claudin18.2 (CLDN18.2) antibody, and the addition of zolbetuximab in combination with fluoropyrimidine and oxaliplatin as a first-line treatment for CLDN18.2-positive and HER2-negative gastric or gastroesophageal junction adenocarcinoma has been shown to improve survival. The secondary endpoints are the time to treatment failure, progression-free survival, overall survival, response rate, incidence of adverse events, and incidence of Grade 3 or higher adverse events. The results will be used to evaluate the feasibility of the treatment and are expected to be used to evaluate whether future trials can be conducted.
    Clinical protocol • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative • CLDN18.2 positive • CLDN18.2 positive + HER-2 negative
    |
    oxaliplatin • Lonsurf (trifluridine/tipiracil) • Vyloy (zolbetuximab-clzb)
    20d
    Trifluridine/tipiracil enhances radiation-induced abscopal effects and augments PD-1 blockade in gastric cancer. (PubMed, Sci Rep)
    PD-1 expression on CD8⁺ T cells increased after FTD/TPI + RT; adding anti-PD-1 further suppressed the second tumor growth. Our findings support clinical trials of this triple-combination strategy in advanced GC, particularly in subgroups refractory to immune checkpoint blockade.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    Lonsurf (trifluridine/tipiracil)
    22d
    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 | Trial completion date: Mar 2026 --> Nov 2026
    Trial completion date
    |
    Avastin (bevacizumab) • capecitabine • Lonsurf (trifluridine/tipiracil)
    22d
    GOBLET: A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab (clinicaltrials.gov)
    P1/2, N=122, Active, not recruiting, Oncolytics Biotech | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • Reolysin (pelareorep)
    23d
    The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, CytoDyn, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    RAS wild-type
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Vyrologix (leronlimab)
    24d
    Late-line Systemic Therapy in Metastatic Colorectal Cancer: A Narrative Review and Australian Expert Perspective. (PubMed, Clin Colorectal Cancer)
    Agents such as trifluridine/tipiracil, regorafenib, and fruquintinib offer additional benefit in heavily pretreated mCRC. Anticipated paradigm shifts with novel agents may further refine management strategies and improve outcomes for these patients. As the landscape evolves, ongoing multidisciplinary collaboration will be essential in optimizing both patient selection and therapy sequencing as new options become available.
    Review • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Stivarga (regorafenib) • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)
    28d
    A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001) (clinicaltrials.gov)
    P3, N=464, Active, not recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    paclitaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • arcotatug tavatecan (TAK-921)
    1m
    FRUQUITAS trial: Study design of an ENGIC intergroup randomized phase III of trifluridine/tipiracil +/- fruquintinib in pre-treated metastatic gastro-oesophageal adenocarcinoma. (PubMed, Dig Liver Dis)
    ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS is designed to determine whether VEGFR inhibition with fruquintinib plus trifluridine/tipiracil can meaningfully improve survival outcomes in pre-treated mOGC.
    P3 data • Journal
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    FLT1 (Fms-related tyrosine kinase 1)
    |
    Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)