^
    1m
    PROTECT-1: Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=33, Recruiting, The First Affiliated Hospital of Xiamen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • Cosela (trilaciclib)
    2ms
    PROTECT-2: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=49, Not yet recruiting, The First Affiliated Hospital of Xiamen University
    New P2 trial
    |
    Cosela (trilaciclib) • Jiataile (sacituzumab tirumotecan)
    3ms
    Properties of FDA-approved small molecule protein kinase inhibitors: a 2025 update. (PubMed, Pharmacol Res)
    Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis)...The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85 FDA-approved drugs have a least one Lipinski rule of 5 violation.
    FDA event • Review • Journal
    |
    MAP2K1 (Mitogen-activated protein kinase kinase 1)
    |
    Xalkori (crizotinib) • sorafenib • imatinib • sunitinib • Ensacove (ensartinib) • Torisel (temsirolimus) • Gomekli (mirdametinib) • Lazcluze (lazertinib) • Ojemda (tovorafenib) • Cosela (trilaciclib) • tofacitinib • Litfulo (ritlecitinib)
    3ms
    PROTECT-1: Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, The First Affiliated Hospital of Xiamen University
    New P2 trial
    |
    docetaxel • Cosela (trilaciclib)
    4ms
    Randomized controlled clinical study on the efficacy and safety of first-line treatment of extensive stage small cell lung cancer with combination therapy of trilaciclib, envafolimab, etoposide, and carboplatin (ChiCTR2500099059)
    P2, N=52, Recruiting, Shanghai Chest Hospital; Shanghai Chest?Hospital
    New P2 trial
    |
    carboplatin • etoposide IV • Enweida (envafolimab) • Cosela (trilaciclib)
    4ms
    An exploratory, controlled Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in combination with PD-1 monoclonal antibody and first-line chemotherapy in patients with advanced non-small cell lung cancer (ChiCTR2500098340)
    P2, N=40, Not yet recruiting, Liaoning Cancer Hospital & Institute; Liaoning Cancer Hospital & Institute
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • ALK mutation • RET mutation • MET mutation • KRAS G12
    |
    carboplatin • paclitaxel • pemetrexed • Cosela (trilaciclib)
    4ms
    Myelopreservation with trilaciclib in patients with advanced ovarian carcinoma receiving paclitaxel and carboplatin: a randomized, double-blind, placebo-controlled phase II study (ChiCTR2500097713)
    P=N/A, N=71, Not yet recruiting, Sun yat-sen memorial hospital, Sun yat-sen university; Sun yat-sen memorial hospital, Sun yat-sen university
    New trial
    |
    carboplatin • paclitaxel • Cosela (trilaciclib)
    4ms
    A Multi-Cohort, Open-Label, Exploratory Clinical Study on the Myeloprotective and Immunomodulatory Effects of Trilaciclib in the Context of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Post-Surgery and First-Line Chemotherapy for Advanced Disease. (ChiCTR2500097520)
    P4, N=102, Not yet recruiting, Shanxi Province Cancer Hospital; Shanxi Province Cancer Hospital
    New P4 trial
    |
    Cosela (trilaciclib)
    5ms
    A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma. (clinicaltrials.gov)
    P3, N=210, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Initiation date: Apr 2024 --> Oct 2025
    Trial initiation date
    |
    cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • Cosela (trilaciclib)
    6ms
    Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=30, Terminated, G1 Therapeutics, Inc. | Completed --> Terminated; The Sponsor decided to close enrollment to the study on Feb 14, 2023, in order to reallocate resources to other ongoing trilaciclib clinical trials.
    Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    HER-2 negative • ER negative
    |
    Trodelvy (sacituzumab govitecan-hziy) • Cosela (trilaciclib)
    6ms
    A prospective, single-arm, phase II clinical study of recombinant human endostatin in combination with trilaciclib, paclitaxel, carboplatin, and anti-PD-(L)1 as first-line treatment for advanced (stage IIIB-IV) squamous non-small cell lung cancer (ChiCTR2400094918)
    P2, N=40, Shanghai Chest Hospital; Shanghai Chest?Hospital
    New P2 trial
    |
    carboplatin • paclitaxel • Cosela (trilaciclib)
    7ms
    CCRT，LA-HNSCC: Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Hunan Cancer Hospital
    New P2 trial
    |
    cisplatin • Cosela (trilaciclib)
    8ms
    Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma (clinicaltrials.gov)
    P2, N=50, Recruiting, Peking University People's Hospital
    New P2 trial
    |
    lobaplatin (D19466) • Cosela (trilaciclib) • Pinorubin (pirarubicin)
    8ms
    Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Shandong Cancer Hospital and Institute
    New P2 trial • Metastases
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • Cosela (trilaciclib)
    8ms
    COSELA: Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New trial • Real-world evidence • Real-world
    |
    Cosela (trilaciclib)
    8ms
    A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib (clinicaltrials.gov)
    P2, N=22, Recruiting, Fudan University
    New P2 trial
    |
    doxorubicin hydrochloride • cyclophosphamide • Cosela (trilaciclib)
    8ms
    Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin (clinicaltrials.gov)
    P2, N=52, Recruiting, Shanghai Chest Hospital
    New P2 trial • Combination therapy
    |
    carboplatin • etoposide IV • Enweida (envafolimab) • Cosela (trilaciclib)
    10ms
    Trilaciclib Prevents Myelosuppression With Chemoradiotherapy (clinicaltrials.gov)
    P2, N=40, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Enrolling by invitation --> Recruiting
    Enrollment status
    |
    Cosela (trilaciclib)
    10ms
    A Single-Arm, Observational Study to Assess the Efficacy and Safety of Trilaciclib in Extensive Stage Small Cell Lung Cancer Patients with Chemotherapy Induced Grade 3/4 Myelosuppression Following Prior Chemotherapy (ChiCTR2400087694)
    P4, N=20, Recruiting, Tangdu Hospital, Fourth Military Medical University; Tangdu Hospital, Fourth Military Medical University
    New P4 trial
    |
    PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    Cosela (trilaciclib)
    10ms
    A Multicenter, Phase III, Randomized Controlled Trial on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma (ChiCTR2400087886)
    P3, N=192, Not yet recruiting, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    New P3 trial • Metastases
    |
    cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • Cosela (trilaciclib)
    10ms
    The myeloprotective effect of the CDK4/6 inhibitor, trilaciclib, in patients with locally advanced nasopharyngeal carcinoma receiving induction chemotherapy: a phase II clinical trial (ChiCTR2400087929)
    P2, N=10, Not yet recruiting, The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University
    New P2 trial • Metastases
    |
    Cosela (trilaciclib)
    11ms
    Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial • Metastases
    |
    carboplatin • Cosela (trilaciclib)
    11ms
    A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients (clinicaltrials.gov)
    P2, N=38, Recruiting, Sun Yat-sen University
    New P2 trial
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CDK4 (Cyclin-dependent kinase 4) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • FOXP3 (Forkhead Box P3) • IL17A (Interleukin 17A) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Cosela (trilaciclib)
    11ms
    Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=30, Completed, G1 Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Trodelvy (sacituzumab govitecan-hziy) • Cosela (trilaciclib)
    12ms
    PRESERVE 2: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P3, N=194, Completed, G1 Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> May 2024
    Trial completion • Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    carboplatin • gemcitabine • Cosela (trilaciclib)
    1year
    Trilaciclib Prevents Myelosuppression With Chemoradiotherapy (clinicaltrials.gov)
    P2, N=40, Enrolling by invitation, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial
    |
    Cosela (trilaciclib)
    1year
    Study of Trilaciclib and Lurbinectidin (clinicaltrials.gov)
    P2, N=30, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Jul 2026 --> Dec 2027 | Trial primary completion date: Jul 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Zepzelca (lurbinectedin) • Cosela (trilaciclib)
    over1year
    Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics. (PubMed, J Clin Pharmacol)
    Trilaciclib is a first-in-class, intravenous cyclin-dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer receiving a platinum/etoposide-containing or topotecan-containing regimen. Ad hoc analysis using National Cancer Institute classification showed similar results. The US Food and Drug Administration-approved trilaciclib dose of 240 mg/m2 should be reduced by ∼30%, to 170 mg/m2, for patients with moderate or severe HI.
    PK/PD data • Journal
    |
    CDK4 (Cyclin-dependent kinase 4)
    |
    etoposide IV • topotecan • Cosela (trilaciclib)
    over1year
    the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Henan Cancer Hospital
    New P2 trial • Metastases
    |
    Cosela (trilaciclib)
    over1year
    An Phase III Study, Multicenter，Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma. (clinicaltrials.gov)
    P3, N=210, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P3 trial • Metastases
    |
    cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • Cosela (trilaciclib)
    over1year
    PRESERVE3: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab (clinicaltrials.gov)
    P2, N=92, Terminated, G1 Therapeutics, Inc. | Active, not recruiting --> Terminated; Sponsor no longer pursuing trila for the indication.
    Trial termination • Metastases
    |
    cisplatin • carboplatin • gemcitabine • Bavencio (avelumab) • Cosela (trilaciclib)
    over1year
    Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, G1 Therapeutics, Inc. | Trial primary completion date: Jun 2023 --> Nov 2023
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • ER negative • PGR negative
    |
    Trodelvy (sacituzumab govitecan-hziy) • Cosela (trilaciclib)
    over1year
    Myeloprotection With Trilaciclib in Pan-cancer Population (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, Sun Yat-sen University
    New P2 trial • Pan tumor • Metastases
    |
    carboplatin • paclitaxel • Cosela (trilaciclib)
    over1year
    A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    oxaliplatin • irinotecan • Cosela (trilaciclib)
    over1year
    ToPCourT: Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, Wake Forest University Health Sciences | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • Cosela (trilaciclib)
    over1year
    Properties of FDA-approved small molecule protein kinase inhibitors: a 2024 update. (PubMed, Pharmacol Res)
    Six drugs (abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, upadacitinib) are used for the treatment of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis)...The following seven drugs received FDA approval in 2023: capivasertib (HER2-positive breast cancer), fruquintinib (metastatic colorectal cancer), momelotinib (myelofibrosis), pirtobrutinib (mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma), quizartinib (Flt3-mutant acute myelogenous leukemia), repotrectinib (ROS1-positive lung cancer), and ritlecitinib (alopecia areata). All of the FDA-approved drugs are orally effective with the exception of netarsudil, temsirolimus, and trilaciclib. This review summarizes the physicochemical properties of all 80 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, polar surface area, potency, solubility, lipophilic efficiency, and ligand efficiency.
    FDA event • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • FLT3 (Fms-related tyrosine kinase 3) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
    |
    HER-2 positive • FLT3 mutation • ROS1 positive
    |
    Vanflyta (quizartinib) • Torisel (temsirolimus) • Truqap (capivasertib) • Augtyro (repotrectinib) • Fruzaqla (fruquintinib) • Jaypirca (pirtobrutinib) • Cosela (trilaciclib) • Ojjaara (momelotinib) • tofacitinib • Litfulo (ritlecitinib)
    over1year
    A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    New P2 trial
    |
    oxaliplatin • irinotecan • Cosela (trilaciclib)
    over1year
    SMA-BC-002: Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy (clinicaltrials.gov)
    P2, N=116, Recruiting, wang shusen | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • ER negative • PGR negative
    |
    Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • cyclophosphamide • epirubicin • Cosela (trilaciclib)
    almost2years
    Assessment of hospitalizations and cytopenia events among patients with extensive stage small cell lung cancer (ES-SCLC) receiving chemotherapy with trilaciclib. (ASCO-QC 2023)
    Eligible patients met literature-based criteria for ES-SCLC using International Classification of Diseases, 10th Revision (ICD-10) diagnosis codes, received platinum/etoposide- or topotecan-based chemotherapy regimens after diagnosis, and were continuously enrolled ≥ 30 days preceding and following chemotherapy initiation. This real-world study demonstrated that receiving trilaciclib prior to chemotherapy treatment was associated with a lower rates of hospitalizations and cytopenia events, suggesting trilaciclib may prevent adverse events associated with treatment for ES-SCLC.
    Clinical
    |
    etoposide IV • topotecan • Cosela (trilaciclib)
    almost2years
    Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study (clinicaltrials.gov)
    P4, N=30, Completed, Jiangsu Simcere Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Nov 2022
    Trial completion • Trial completion date • Real-world evidence • Real-world
    |
    carboplatin • etoposide IV • topotecan • Cosela (trilaciclib)
    almost2years
    Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan (clinicaltrials.gov)
    P4, N=302, Recruiting, G1 Therapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    topotecan • Cosela (trilaciclib)
    almost2years
    Real-World Outcomes of Trilaciclib Among Patients with Extensive-Stage Small Cell Lung Cancer Receiving Chemotherapy. (PubMed, Adv Ther)
    The existing evidence suggests that trilaciclib may reduce single and multilineage grade ≥ 3 myelosuppressive HAEs and cytopenia-related healthcare utilization among patients with ES-SCLC in the real world. It is a promising new treatment for CIM prevention in ES-SCLC and may bring greater benefits to first-line trilaciclib initiators. Future studies are recommended to further evaluate the real-world effectiveness of trilaciclib.
    Review • Journal • Real-world evidence • Real-world
    |
    Cosela (trilaciclib)