Trilaciclib's effect on preventing blood cell reduction during cancer treatment
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
This study is testing if Trilaciclib can help prevent low blood cell counts in patients with small cell lung cancer who are receiving chemotherapy and radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06490081 on ClinicalTrials.gov |
What this trial studies
This study evaluates how Trilaciclib can protect against myelosuppression in patients with limited-stage small cell lung cancer undergoing concurrent chemoradiotherapy. It focuses on the incidence of severe neutropenia and hematological toxicity, while also exploring the relationship between gut microbiota changes and myelosuppression. Patients will receive Trilaciclib prior to chemotherapy and radiotherapy to assess its protective effects. The study aims to provide insights into both the drug's efficacy and the role of gut health in treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with limited-stage small cell lung cancer who have an ECOG performance status of 0-2.
Not a fit: Patients with brain metastases, active infections, or significant autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of blood cell depletion in patients undergoing chemotherapy for lung cancer.
How similar studies have performed: Other studies have shown promising results with similar protective approaches in chemotherapy, but the specific use of Trilaciclib in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xinrong Lian
- Email: 15810538030@163.com
- Phone: 010-87787692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.