Clinical trial · Interventional
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy
To Evaluate the Protective Effect of Trilaciclib on Myelosuppression in Patients With Limited-stage Small Cell Lung Cancer Associated With Concurrent Chemoradiotherapy and Discuss the Effect of Gut Microbiota Changes on Myelosuppression
NCT06490081CI-TRIAL-00081006unknownPhase 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)
To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression
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 |
|---|---|---|---|
| Myelosuppression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trilaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trilaciclib combined with concurrent chemoradiotherapy
- description
- Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer
- interventionNames
- Drug: Trilaciclib
Primary outcomes (3)
- measure
- Occurrence of severe neutropenia
- timeFrame
- 14 days
- description
- Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy
- measure
- Duration of severe neutropenia
- timeFrame
- 5 days
- description
- Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC\<1.0×10\^9/L for more than 5 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. The histopathology is limited-stage small cell lung cancer. 2. ECOG score 0-2. 3. Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination). 4. It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin. 5. Understand and can sign informed consent Exclusion Criteria: 1. Brain metastases with clinical symptoms require local radiotherapy or hormone therapy. 2. Active infections require systemic treatment. 3. Subjects with active, known or suspected autoimmune disease or history of autoimmune disease. 4. Combined with other tumors. 5. The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.
References
Publications (0)
Data not yet available
No reference posted for this study.