Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
Recruiting
Phase 2Interventional Study
Non-Small Cell Lung CancerMyelosuppression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
33 (estimated)
Sponsor
The First Affiliated Hospital of Xiamen University · Other
Who this trial is looking for
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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.
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Status
Eligibility 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…
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.
Contacts
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