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.
Age ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
Unresectable stage III/IV non-small cell lung cancer (NSCLC);
Recurrent or metastatic breast cancer (BC);
History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease;
Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiation or steroid therapy;
Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug;
Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug;
Parallel
Trilaciclib Injection
DrugExperimental: trilaciclib group Intervention: Drug: Trilaciclib Injection \[Cosela\] 240 mg/m\^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
Paclitaxel
DrugDrug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.
Carboplatin
Drugarea under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.
Occurrence of grade 3/4 neutropenia within 6 cycles
Percentage of patients with at least one absolute neutrophil count (ANC) \< 1.0 × 10 \^ 9/L in total number of patients included in the analysis set.
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This trial is not recruiting at the moment. You can still explore other options:
