^
    4d
    Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Hebei Medical University Fourth Hospital
    New P1 trial
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    Cosela (trilaciclib)
    12d
    Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=120, Not yet recruiting, Pharmacosmos A/S
    New P3 trial
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    Cosela (trilaciclib)
    13d
    CDK4/6 inhibition mitigates chemotherapy-induced expansion of TP53-mutant clonal hematopoiesis. (PubMed, Nat Genet)
    Here, in four randomized clinical trials, we show that the CDK4/6 inhibitor trilaciclib, given in conjunction with a variety of chemotherapeutic regimens and across diverse populations of patients with cancer, mitigates chemotherapy-related expansion of CH clones with mutations in DNA damage response genes, including TP53. This finding was also observed in a syngeneic mouse model of TP53-mutant CH, demonstrating that CDK4/6 inhibition blocks platinum-induced TP53 competitive repopulation through promoting hematopoietic stem and progenitor quiescence and decreasing the stemness advantage of TP53-mutant clones. This represents a proof of concept for a potential pharmacologic strategy to block chemotherapy-induced expansion of preleukemic TP53-mutant clones.
    Clinical • Journal
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    TP53 (Tumor protein P53)
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    TP53 mutation
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    Cosela (trilaciclib)
    18d
    ToPCourT protocol: a phase II trial of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced/unresectable or metastatic triple-negative breast cancer. (PubMed, Future Oncol)
    The primary endpoint is overall response. Key secondary endpoints include progression-free survival, duration of response, and overall survival.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06027268.
    P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive
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    Keytruda (pembrolizumab) • carboplatin • gemcitabine • Cosela (trilaciclib)
    2ms
    Evaluating the Efficacy and Safety of Trilaciclib in Patients Receiving First-line Sintilimab Plus Chemotherapy for Advanced Driver Gene-negative Non-squamous Non-Small Cell Lung Cancer (ChiCTR2600117016)
    P=N/A, N=80, Not yet recruiting, Shengjing Hospital of China Medical University; Shengjing Hospital of China Medical University
    New trial
    |
    carboplatin • Tyvyt (sintilimab) • pemetrexed • Cosela (trilaciclib)
    2ms
    A non-inferiority, randomized, controlled, multicenter, phase II clinical study was conducted to evaluate the efficacy and safety of triaciclib in the first-line treatment of advanced squamous non-small cell lung cancer with paclitaxel or albumin-paclitaxel combined with carboplatin and tislelizumab (ChiCTR2500115243)
    P2, N=196, Not yet recruiting, Dongguan People's Hospital; Dongguan People's Hospital
    New P2 trial
    |
    carboplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • Cosela (trilaciclib)
    2ms
    the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib (clinicaltrials.gov)
    P2, N=41, Enrolling by invitation, Henan Cancer Hospital | Not yet recruiting --> Enrolling by invitation | Trial primary completion date: Apr 2025 --> Jan 2026
    Enrollment open • Trial primary completion date
    |
    Cosela (trilaciclib)
    5ms
    Trilaciclib triggers a neutrophil-related immune response and sensitizes non-small cell lung cancer to anti-PD-1 therapy. (PubMed, Cell Rep Med)
    Additionally, activated CD8+ T cells recruit and activate neutrophils, forming a positive feedback loop. Combining trilaciclib with anti-PD-1 antibodies presents a promising strategy for NSCLC treatment.
    Journal
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    CD8 (cluster of differentiation 8) • STING (stimulator of interferon response cGAMP interactor 1) • CD177 (CD177 Molecule)
    |
    Cosela (trilaciclib)
    5ms
    A Prospective Phase II Clinical Study of Trilaciclib for Preventing Myelosuppression in Patients with Locally Advanced Nasopharyngeal Carcinoma, Esophageal Carcinoma, or Cervical Carcinoma Undergoing Induction Chemotherapy Combined with Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy (ChiCTR2500110354)
    P2, N=161, Not yet recruiting, The First Affiliated Hospital, Air Force Medical University; The First Affiliated Hospital, Air Force Medical University
    New P2 trial
    |
    Cosela (trilaciclib)
    5ms
    A Prospective, Multicenter, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Trilaciclib in Patients with Locally Advanced Squamous Cell Lung Cancer Receiving Concurrent Chemoradiotherapy (ChiCTR2500109840)
    P2, N=32, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P2 trial
    |
    Cosela (trilaciclib)
    5ms
    A prospective, single-arm, exploratory Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in the first-line treatment of locally advanced cervical cancer patients with paclitaxel combined with carboplatin and radiotherapy (ChiCTR2500108685)
    P=N/A, N=30, Not yet recruiting, Tianjin Cancer Hospital Airport Hospital; Tianjin Cancer Hospital Airport Hospital
    New trial
    |
    carboplatin • paclitaxel • Cosela (trilaciclib)
    5ms
    Efficacy and Safety of Trilaciclib in Myeloprotection during Chemotherapy for Pediatric Patients with Parameningeal Rhabdomyosarcoma with Meningeal Invasion (ChiCTR2500108628)
    P4, N=30, Not yet recruiting, Beijing Children’s Hospital, Capital Medical University; Beijing Children’s Hospital, Capital Medical University
    New P4 trial
    |
    Cosela (trilaciclib)