Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Coagulants

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Aprotinin

Patients with lung adenocarcinoma were treated with Trilaciclib (240mg/m2, d1, within 4 hours before each chemotherapy) combined with pemetrexed and carboplatin (dose according to the guideline recommendation, d1, Q3W). "For squamous lung cancer, Trilaciclib (d1, 240mg/m2, 4 hours before each chemotherapy) plus paclitaxel/albumin-bound paclitaxel plus carboplatin (dose according to guideline recommendation, d1), Q3W." In the second cycle, patients were left to their own discretion with or without treaclib combination therapy.

Patients with lung adenocarcinoma were given Trilaciclib combined with pemetrexed and carboplatin, Q3W; For patients with lung squamous cell carcinoma,Trilaciclib combined with paclitaxel/albumin-bound paclitaxel and carboplatin, Q3W. From cycle 2 onwards, patients chose whether to use trasylol with chemotherapy.

Trilaciclib Injection

liu C yang, M.D.

The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.

This is a single-arm, exploratory clinical study. Eligible patients were treated with Trilaciclib before the first cycle of chemotherapy, and their peripheral blood samples were tested on days 3,7,14,21±1 after chemotherapy. At the same time, the incidence of FN, the use of antibiotics, the safety, the number of patients who delayed the second cycle of treatment, the number of patients who reduced the dose of chemotherapy, the number of patients who reduced the dose of chemotherapy due to neutropenia, and the number of patients who discontinued chemotherapy were observed.

A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

A Prospective, Single-arm, Exploratory Clinical Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

Incidence of febrile neutropenia in the first treatment cycle

Occurrence and severity of AEs by NCI CTCAE v5.0

Antibiotic Use rate in the first treatment cycle

Number of delays in the second treatment cycle due to myelosuppression

Number of chemotherapy dose reductions in the second treatment cycle due to myelosuppression

Taixing People's Hospital

Director

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Recurrence

Carcinoma

Breast Neoplasms

Carcinoma, Squamous Cell

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Head and Neck Neoplasms

Tubulin Modulators

Antimitotic Agents

Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection \[Cosela\] 240 mg/m\^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.

area under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.

Ruihua Xu, PhD

Yanxia Shi

The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:

* effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy
* does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type

Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.

Myeloprotection With Trilaciclib in Pan-cancer Population

Efficacy and Safety of Trilaciclib in Myeloprotection During Chemotherapy for Advanced/Recurrent Malignant Solid Tumors - A Phase II Study

Percentage of patients with at least one absolute neutrophil count (ANC) \< 1.0 × 10 \^ 9/L in total number of patients included in the analysis set.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC	NCT06328049	NSCLC	Trilaciclib Inj...	18 Years -	Taixing People's Hospital
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC	NCT06328049	NSCLC	Trilaciclib Inj...	18 Years -	Taixing People's Hospital
Myeloprotection With Trilaciclib in Pan-cancer Population	NCT06297811	Non-Small Cell ... Breast Cancer Endometrial Can... Cervical Cancer Head And Neck S...	Trilaciclib Inj... Paclitaxel Carboplatin	18 Years -	Sun Yat-sen University
Myeloprotection With Trilaciclib in Pan-cancer Population	NCT06297811	Non-Small Cell ... Breast Cancer Endometrial Can... Cervical Cancer Head And Neck S...	Trilaciclib Inj... Paclitaxel Carboplatin	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for trilaciclib injection