PROTECT-1Trilaciclib and Docetaxel for Advanced Non-Small Cell Lung Cancer
Trilaciclib combined with Docetaxel
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: May 9, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on finding a new treatment approach for individuals with advanced stages of non-small cell lung cancer (NSCLC) that has spread or is difficult to treat with standard methods. The study is testing a combination of two drugs, trilaciclib and docetaxel, to see if this combination can improve outcomes for patients who have already undergone initial treatments. This research is important because finding more effective treatments could lead to better survival rates and quality of life for people with this type of cancer. Participants in the study will receive trilaciclib before undergoing chemotherapy with docetaxel over a period of four cycles. Throughout the trial, researchers will monitor changes in participants' blood counts and watch for side effects such as infections or the need for blood transfusions. Tumor sizes will be evaluated using imaging tests every six weeks to check for any changes. Even if participants stop taking the study drugs due to side effects, their progress will still be followed through imaging until their condition worsens or they leave the study for other reasons.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be included in this study: 1. Age ≥ 18 years old, regardless of gender; 2. 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 immunotherapy). B. Patients with positive driver genes must have received at least one line chemotherapy after standard targeted therapy has failed. C. Definition of driver genes: EGFR (including 19del, L858R, S768I, L861Q, and/or G719X), BRAF V600E, NTRK, MET14 exon skipping mutation, RET, ROS1, etc. 3. At least one measurable lesion that meets the RECIST 1.1 criteria exists; 4. 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) ≥ 60mL/min (Cockcroft Gault formula); Total bilirubin ≤ 1.5xupper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN or ≤ 5×ULN (for patients with liver metastases); Albumin ≥ 30 g/L; 5. ECOG PS score 0-2; 6. Expected survival time ≥ 3 months; 7. 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 after the last dose; 8. Understand and sign the informed consent form. Exclusion Criteria: 1. Previously received treatment with docetaxel; 2. 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); 3. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); 4. Stroke or cardiovascular events within the first 6 months of enrollment; 5. When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF\>500msec； 6. Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals; 7. Previously received hematopoietic stem cell or bone marrow transplantation; 8. Allergies to research drugs or their components; 9. The researchers believe that it is not suitable to participate in this study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The First Affiliated Hospital of Xiamen University
Xiamen, ChinaOpen The First Affiliated Hospital of Xiamen University in Google Maps