Clinical trial · Interventional
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib
A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib
NCT06370416CI-TRIAL-00101776enrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trilaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trilaciclib group
- description
- 240mg/m2, intravenous infusion for 30 minutes, and administration completed within 4 hours before daily chemotherapy;
- interventionNames
- Drug: Trilaciclib
Primary outcomes (1)
- measure
- The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
- timeFrame
- 1-2 weeks after chemotherapy
- description
- Neutrophils ≤ 1.0\*109
Secondary outcomes (3)
- measure
- The incidence of grade 4 neutropenia during chemotherapy treatment
- timeFrame
- 1-2 weeks after chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old, regardless of gender; * Patients with locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1.1 criteria * Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum+pemetrexed/docetaxel/albumin paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If first-line chemotherapy treatment does not combine with immunotherapy, subsequent increase in immunotherapy patients will not be counted as an increase in the number of treatment lines, and the number of treatment lines in this trial is limited to the number of chemotherapy treatment lines) * The laboratory inspection meets the standards * ECOG PS score 0-1 points; * Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose; * Understand and sign the informed consent form. Exclusion Criteria: * Diagnosed as other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ); * Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV); * Stroke or cardiovascular events within 6 months prior to enrollment * When screening, QTcF interval\>480msec, for patients with implanted ventricular pacemakers, QTcF\>500msec * Previously received hematopoietic stem cell or bone marrow transplantation * Allergy to the investigational drug or its components; * The researchers believe that it is not suitable to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.