drugset / Trial / NCT06297811

Myeloprotection With Trilaciclib in Pan-cancer Population

NCT06297811

Phase 2 Not yet recruiting 132 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are: * effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy * does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.

Timeline

Start
2024-03-01
Primary completion
2025-09-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Trilaciclib Unknown 240 mg/m2 Intravenous
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous