Clinical trial NCT05071703: Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
Official title: Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: G1 Therapeutics, Inc.
First posted: 2021-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of severe neutropenia (SN)
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary outcomes:
measure: Incidence of grade 3 and 4 hematologic toxicity
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Incidence of intravenous or oral antibiotic administration in treatment
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Incidence of G-CSF treatment
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Incidence of red blood cell (RBC) transfusions at or after week 5
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: The incidence of ESA administration in treatment
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: The incidence of TPO administration in treatment
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: The incidence of platelet transfusion
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: The number and frequency of all-caused chemotherapy drugs reduction
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: 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 )
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Incidence of infectious serious adverse events
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Incidence of pulmonary infection serious adverse events
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: The incidence of febrile neutropenia
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Objective response rate
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: duration of response
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Progression-free survival time
timeFrame: during Trilaciclib plus chemotherapy assessed up to 6 months
measure: Disease control rate
timeFrame: during chemotherapy assessed up to 6 months
measure: verall survival
timeFrame: maximun up to 1.5 years
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
Study officials:
affiliation: Hainan General Hospital
name: Yongxing Chen
role: PRINCIPAL_INVESTIGATOR
References: