Clinical Trials

Numerous clinical trials, spanning Phase 1 through Phase 4, evaluate the therapeutic efficacy of trilaciclib across chemotherapy-induced myelosuppression and diverse oncological indications, including triple-negative breast cancer, small cell and non-small cell lung cancers, diffuse large B-cell lymphoma, and biliary tract neoplasms. Sponsored by pharmaceutical companies and academic institutions, these studies range from actively recruiting to completed pivotal trials, with select indications achieving marketing approval.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01042379 RECRUITING
Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer
QuantumLeap Healthcare Collaborative
 2010-03-01 PHASE2
NCT06698965 RECRUITING
Lung Cancer, Small Cell
Shanghai Chest Hospital
 2024-10-13 PHASE2
NCT07736001 NOT_YET_RECRUITING
Tumor Patients
Tianjin Medical University Cancer Institute and Hospital
 2026-07
NCT05874401 RECRUITING
Extensive-stage Small-cell Lung Cancer
Pharmacosmos A/S
 2023-10-18 PHASE4
NCT07679997 NOT_YET_RECRUITING
Head & Neck Squamous Cell Carcinoma
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2026-06-01 PHASE2
NCT07160283 NOT_YET_RECRUITING
Biliary Tract Neoplasms; Pancreatic Neoplasms
The Second Affiliated Hospital of Shandong First Medical University
 2025-09-01 PHASE2
NCT07490236 RECRUITING
Trilaciclib; CDK4/6-dependent Solid Tumors
Hebei Medical University Fourth Hospital
 2023-01-01 PHASE1
NCT06027268 ACTIVE_NOT_RECRUITING
Metastatic Triple-Negative Breast Cancer
Wake Forest University Health Sciences
 2024-01-10 PHASE2
NCT07473128 RECRUITING
Limited Stage Small Cell Lung Cancer
Pharmacosmos A/S
 2026-06-30 PHASE3
NCT06364904 NOT_YET_RECRUITING
Bladder Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2025-10 PHASE3
NCT06992739 RECRUITING
NSCLC (Advanced Non-small Cell Lung Cancer); EGFR; Myelosuppression
The First Affiliated Hospital of Xiamen University
 2025-12-08 PHASE2
NCT05978648 RECRUITING
Breast Neoplasms
wang shusen
 2023-09-20 PHASE2
NCT05862610 NOT_YET_RECRUITING
Breast Neoplasm
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2023-07-30 PHASE2
NCT05578326 RECRUITING
Lung Cancer; Small-cell Lung Cancer
UNC Lineberger Comprehensive Cancer Center
 2022-10-12 PHASE2
NCT07255612 NOT_YET_RECRUITING
Breast Cancer
Sun Yat-sen University
 2026-11-04 PHASE2
NCT06699472 RECRUITING
Ewing Sarcoma; Myelosuppression
Fudan University
 2024-10-31 PHASE2
NCT06714266 NOT_YET_RECRUITING
Head and Neck Squamous Cell Carcinoma (HNSCC)
Shandong Cancer Hospital and Institute
 2024-12-15 PHASE2
NCT06929936 RECRUITING
Non-Small Cell Lung Cancer; Myelosuppression
The First Affiliated Hospital of Xiamen University
 2025-05-09 PHASE2
NCT06370416 ENROLLING_BY_INVITATION
Non-small Cell Lung Cancer
Henan Cancer Hospital
 2024-04-02 PHASE2
NCT06490081 UNKNOWN
Myelosuppression
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2024-06-26 PHASE2
NCT05910034 UNKNOWN
Advanced Non-Small Cell Lung Cancer
Fudan University
 2023-07-01 PHASE2
NCT06569459 UNKNOWN
Esophageal Cancer
The First Affiliated Hospital with Nanjing Medical University
 2024-07-09 PHASE2
NCT06752798 RECRUITING
Head and Neck Cancer Squamous Cell Carcinoma
Hunan Cancer Hospital
 2024-12-30 PHASE2
NCT06297811 NOT_YET_RECRUITING
Non-Small Cell Lung Cancer; Breast Cancer; Endometrial Cancer; Cervical Cancer; Head And Neck Squamous Cell Carcinomas
Sun Yat-sen University
 2024-03-01 PHASE2
NCT06714383 RECRUITING
Osteosarcoma
Peking University People's Hospital
 2024-11-13 PHASE2
NCT06151262 RECRUITING
Pancreatic Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2024-01-20 PHASE2
NCT06955156 UNKNOWN
Triple Negative Breast Cancer
QIAO LI
 2023-07-03 PHASE2
NCT06328049 UNKNOWN
NSCLC
Taixing People's Hospital
 2023-08-10 PHASE2
NCT06217003 UNKNOWN
Osteosarcoma
The First Affiliated Hospital of Xinxiang Medical College
 2024-02-01 PHASE2
NCT06569485 RECRUITING
DLBCL
Sun Yat-sen University
 2024-05-23 PHASE2
NCT06332287 UNKNOWN
NSCLC
Jiangsu Province Nanjing Brain Hospital
 2023-05-01 PHASE2
NCT05900921 UNKNOWN
Advanced Squamous Non-Small-Cell Lung Cancer
Sichuan University
 2023-07-01 PHASE2
NCT04799249 COMPLETED
TNBC - Triple-Negative Breast Cancer; Breast Cancer
G1 Therapeutics, Inc.
 2021-05-14 PHASE3
NCT05113966 TERMINATED
Triple Negative Breast Cancer
G1 Therapeutics, Inc.
 2021-12-08 PHASE2
NCT04887831 TERMINATED
Urothelial Carcinoma; Bladder Cancer; Myelosuppression Adult; Chemotherapy-induced Neutropenia; Metastatic Bladder Cancer
G1 Therapeutics, Inc.
 2021-06-04 PHASE2
NCT04607668 TERMINATED
Colorectal Cancer Metastatic; Myelosuppression-Adult; Chemotherapeutic Toxicity
G1 Therapeutics, Inc.
 2021-01-06 PHASE3
NCT05112536 COMPLETED
Triple Negative Breast Cancer; Breast Cancer
G1 Therapeutics, Inc.
 2022-03-03 PHASE2
NCT05071703 COMPLETED
Extensive-stage Small-cell Lung Cancer
Jiangsu Simcere Pharmaceutical Co., Ltd.
 2021-08-11 PHASE4
NCT04863248 TERMINATED
Metastatic Non-Small Cell Lung Cancer; NSCLC; Lung Cancer
G1 Therapeutics, Inc.
 2021-04-30 PHASE2
NCT04902885 COMPLETED
Extensive-stage Small-cell Lung Cancer
Jiangsu Simcere Pharmaceutical Co., Ltd.
 2021-05-25 PHASE3
NCT02978716 TERMINATED
Triple-Negative Breast Neoplasms; Breast Neoplasm; Breast Cancer; Triple-Negative Breast Cancer
G1 Therapeutics, Inc.
 2017-02-02 PHASE2
NCT02514447 COMPLETED
Small Cell Lung Cancer
G1 Therapeutics, Inc.
 2015-10-05 PHASE1; PHASE2
NCT03041311 COMPLETED
Small Cell Lung Cancer
G1 Therapeutics, Inc.
 2017-06-29 PHASE2
NCT02499770 COMPLETED
Small Cell Lung Cancer
G1 Therapeutics, Inc.
 2015-06-26 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the Trilaciclib dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trilaciclib dihydrochloride potently binds to cyclin-dependent kinases 4 and 6 (CDK4/6), thereby arresting hematopoietic stem and progenitor cells in the G1 phase of the cell cycle to prevent chemotherapy-induced cellular damage. This transient cell cycle arrest protects bone marrow function during cytotoxic therapy, effectively reducing chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer and triple-negative breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.