Clinical trial · Interventional
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
NCT06328049CI-TRIAL-00075387unknownPhase 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)
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.
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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trilaciclib Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trilaciclib plus chemotherapy
- description
- 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.
- interventionNames
- Drug: Trilaciclib Injection
Primary outcomes (1)
- measure
- Incidence of febrile neutropenia (FN)
- timeFrame
- during Trilaciclib plus chemotherapy assessed up to 21 days
- description
- Incidence of febrile neutropenia in the first treatment cycle
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age above 18 years old (including 18 years old)，regardless of gender； * ECOG-PS score of 0-1,； * expected survival≥12 weeks； * There was no tumor deterioration in the 2 weeks prior to study drug treatment. * Advanced non-small cell lung cancer without systemic chemotherapy. * At least one tumor lesion with a maximum diameter ≥10 mm (short diameter ≥15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose. * Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment. * Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment. * All subjects voluntarily participated and signed the informed consent form in person. Exclusion Criteria: * Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); * stroke or cardio-cerebrovascular event within 6 months before enrollment; * QTcF interval \> 480msec at screening or \> 500msec for patients with implanted ventricular pacemakers; * Previous hematopoietic stem cell or bone marrow transplantation; * Allergy to the study drug or its components; * Others considered by the investigator to be unsuitable for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.