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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
• Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
• Measurable or evaluable disease as defined by RECIST v1.1
Locations
Other Locations
Spain
Hospital
RECRUITING
Seville
Contact Information
Primary
Pharmacosmos Clinical and non-clinical Department
info@pharmacosmos.com
+45 5948 5959
Time Frame
Start Date: 2023-10-18
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 302
Treatments
Experimental: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)
Placebo_comparator: Placebo + Topotecan 1.5 mg/m²
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.~Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).
Related Therapeutic Areas
Sponsors
Leads: Pharmacosmos A/S