Extensive-stage Small-cell Lung Cancer
Conditions
Brief summary
This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.
Interventions
DRUGTrilaciclib
* Carboplatin combined with Etoposide (ES-SCLC patients) * plus Topotecan (second/third line ES-SCLC patients)
Sponsors
G1 Therapeutics, Inc.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate and sign informed consent; 2. must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender: 3. Patients with extensive small-cell lung cancer confirmed by histology or cytology 4. Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment
Exclusion criteria
1. Patient is currently participating in other Interventional clinical studies; 2. Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe neutropenia (SN) | during Trilaciclib plus chemotherapy assessed up to 6 months | Incidence of severe neutropenia (SN) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of intravenous or oral antibiotic administration in treatment | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Incidence of G-CSF treatment | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Incidence of red blood cell (RBC) transfusions at or after week 5 | during Trilaciclib plus chemotherapy assessed up to 6 months |
| The incidence of ESA administration in treatment | during Trilaciclib plus chemotherapy assessed up to 6 months |
| The incidence of TPO administration in treatment | during Trilaciclib plus chemotherapy assessed up to 6 months |
| The incidence of platelet transfusion | during Trilaciclib plus chemotherapy assessed up to 6 months |
| The number and frequency of all-caused chemotherapy drugs reduction | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Incidence of grade 3 and 4 hematologic toxicity | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Incidence of infectious serious adverse events | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Incidence of pulmonary infection serious adverse events | during Trilaciclib plus chemotherapy assessed up to 6 months |
| The incidence of febrile neutropenia | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Objective response rate | during Trilaciclib plus chemotherapy assessed up to 6 months |
| duration of response | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Progression-free survival time | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Disease control rate | during chemotherapy assessed up to 6 months |
| verall survival | maximun up to 1.5 years |
| composite end point - Significant hematologic adverse event (occurrence of any of the following events：all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia ) | during Trilaciclib plus chemotherapy assessed up to 6 months |
Countries
China
Outcome results
None listed