Trilaciclib compared to placebo for patients with extensive stage small cell lung cancer receiving topotecan
A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
This study is testing if a new drug called trilaciclib can help people with advanced small cell lung cancer live longer and feel better while they receive chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pharmacosmos A/S Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Seville) |
| Trial ID | NCT05874401 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the effectiveness of trilaciclib in improving overall survival in patients with extensive-stage small cell lung cancer (ES-SCLC) who are receiving topotecan. Participants will be randomly assigned to receive either trilaciclib or a placebo before their chemotherapy treatment. The study includes three phases: screening, treatment, and survival follow-up, with patients monitored until disease progression or other specified endpoints. The goal is to determine if trilaciclib can reduce chemotherapy-induced myelosuppression and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed extensive-stage small cell lung cancer who have experienced disease progression after prior chemotherapy.
Not a fit: Patients with a history of treatment with topotecan or trilaciclib, or those with certain severe health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that enhances survival rates for patients with ES-SCLC undergoing chemotherapy.
How similar studies have performed: Previous studies have shown promising results with trilaciclib in reducing chemotherapy-induced myelosuppression, making this approach a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology 2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination. 3. Measurable or evaluable disease as defined by RECIST v1.1 Exclusion Criteria: 1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC 2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer 3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids 4. Radiotherapy within 2 weeks 5. History of ILD/pneumonitis 6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Where this trial is running
Seville
- Hospital — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Pharmacosmos Clinical and non-clinical Department
- Email: info@pharmacosmos.com
- Phone: +45 5948 5959
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.