^
    8d
    PROTECT-2: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=49, Recruiting, The First Affiliated Hospital of Xiamen University | Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> Dec 2027 | Initiation date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2026 --> Mar 2027
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    EGFR mutation
    |
    Cosela (trilaciclib) • Jiataile (sacituzumab tirumotecan)
    23d
    Study of Trilaciclib and Lurbinectidin (clinicaltrials.gov)
    P2, N=30, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Zepzelca (lurbinectedin) • Cosela (trilaciclib)
    29d
    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
    |
    Cosela (trilaciclib)
    1m
    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
    |
    Cosela (trilaciclib)
    1m
    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
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Cosela (trilaciclib)
    1m
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • Cosela (trilaciclib)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    6ms
    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
    |
    CD8 (cluster of differentiation 8) • STING (stimulator of interferon response cGAMP interactor 1) • CD177 (CD177 Molecule)
    |
    Cosela (trilaciclib)
    6ms
    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)
    6ms
    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)