Actively Recruiting
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Led by Pharmacosmos A/S · Updated on 2025-09-04
302
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
CONDITIONS
Official Title
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of extensive-stage small-cell lung cancer confirmed by biopsy or cytology
- Disease progression during or after prior first or second line chemotherapy with a platinum-containing combination
- Measurable or evaluable disease according to RECIST v1.1 criteria
You will not qualify if you...
- Previous treatment with topotecan or other topoisomerase I inhibitors, or trilaciclib for small-cell lung cancer
- Received chemotherapy, immunotherapy, biologic, investigational, or hormonal cancer therapy within 3 weeks, except for adjuvant hormonal therapy for breast or prostate cancer
- Presence of brain metastases or leptomeningeal disease requiring immediate radiation or steroid treatment
- Radiotherapy within 2 weeks before study entry
- History of interstitial lung disease or pneumonitis
- History of other malignancies unless curatively treated solid tumors with no evidence of disease for 2 or more years or other non-cutaneous cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital
Seville, Spain
Actively Recruiting
Research Team
P
Pharmacosmos Clinical and non-clinical Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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