Trilaciclib to Protect the Blood System in Limited-Stage Small Cell Lung Cancer
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer
Run by Pharmacosmos A/S · NCT07473128 · Data updated 2026-11-12
This trial tests whether trilaciclib can protect blood-forming cells in people with limited-stage small cell lung cancer when given with standard therapy, compared with placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Pharmacosmos A/S Industry-sponsored |
| Locations | 1 site (Oakland, California) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07473128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed limited-stage small cell lung cancer who have recovered from prior surgery and have measurable disease, willing to consent.
✕Probably not a fit
Patients with extensive-stage disease, active cardiovascular disease, or hypersensitivity to study drugs may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 randomized trial evaluating trilaciclib versus placebo in patients with limited-stage small cell lung cancer. Participants will receive trilaciclib or saline as a control, alongside standard treatment, to see if the drug reduces myelosuppression and related safety issues. The study includes adults with confirmed limited-stage disease who have recovered from prior surgery and have measurable disease, excluding those with extensive-stage disease or certain health risks. Primary outcomes focus on myelosuppression and safety, with secondary assessments of efficacy and tolerability. The trial is sponsored by Pharmacosmos A/S with a single investigational site in Oakland, California.
Why it matters
Potential benefit: If successful, trilaciclib could reduce chemotherapy-related blood cell suppression and related complications for patients with limited-stage small cell lung cancer.
How similar studies have gone: Prior studies in related settings have explored myeloprotective strategies; this trial tests a targeted agent with prior exploratory data supporting potential benefit.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of Limited-Stage Small Cell Lung Cancer * Complete recovery from prior anti-tumor surgical procedures * Measurable and evaluable disease through tumor assessment * Willingness to participate and sign informed consent form Exclusion Criteria: * Extensive Stage Small Cell Lung Cancer * Active cardiovascular disease * Known hypersensitivity to trilaciclib, etoposide, carboplatin, cisplatin or any component in their formulations * Pregnant or nursing women
Where it's running
-
Pharmacosmos Investigational Site
Oakland, California, United States Recruiting
Study contacts
- Study coordinator: Pharmacosmos A/S Clinical and non-clinical research
- Email: info@pharmacosmos.com
- Phone: +4559485959
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.