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New treatment option for Non-Small Cell Lung Cancer
Official title Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
ClinicalTrials.gov ID: NCT06929936
What this study is testing
What is Trilaciclib combined with Docetaxel?
Trilaciclib combined with Docetaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, single arm phase II study aimed at patients with locally advanced or metastatic non-small cell lung cancer undergoing second-line or beyond treatment. The aim is to evaluate the bone marrow protective effect of trilaciclib before docetaxel chemotherapy for locally advanced or metastatic NSCLC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all of the following to be included in this study:
- Age ≥ 18 years old, regardless of gender;
- Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen: A. Patients with negative driver genes must have...
- At least one measurable lesion that meets the RECIST 1.1 criteria exists;
- The laboratory test results meet the following criteria: Hemoglobin ≥ 100 g/L (female), 110g/L (male) ,Neutrophil count ≥ 2×109/L Platelet count ≥...
You likely can't join if
- Previously received treatment with docetaxel;
- Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma...
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
- Stroke or cardiovascular events within the first 6 months of enrollment;
- When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF\>500msec；
- Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
See the full eligibility criteria
- Patients must meet all of the following to be included in this study:
- Age ≥ 18 years old, regardless of gender;
- Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen: A. Patients with negative driver genes must have received first line standard treatment (chemotherapy combined with...
- At least one measurable lesion that meets the RECIST 1.1 criteria exists;
- The laboratory test results meet the following criteria: Hemoglobin ≥ 100 g/L (female), 110g/L (male) ,Neutrophil count ≥ 2×109/L Platelet count ≥ 100×109/L; Creatinine ≤15mg/L or creatinine clearance rate (CrCl) ≥...
- ECOG PS score 0-2;
- Expected survival time ≥ 3 months;
- Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months...
- Understand and sign the informed consent form.
- Previously received treatment with docetaxel;
- Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
- Stroke or cardiovascular events within the first 6 months of enrollment;
- When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF\>500msec；
- Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
- Previously received hematopoietic stem cell or bone marrow transplantation;
- Allergies to research drugs or their components;
- The researchers believe that it is not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.