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| Name | Class |
|---|---|
| G1 Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilaciclib, carboplatin, etoposide, Topotecan | Experimental | Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilaciclib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe neutropenia (SN) | Incidence of severe neutropenia (SN) | during Trilaciclib plus chemotherapy assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3 and 4 hematologic toxicity | during Trilaciclib plus chemotherapy assessed up to 6 months | |
| Incidence of intravenous or oral antibiotic administration in treatment | during Trilaciclib plus chemotherapy assessed up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongxing Chen | Hainan General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan General Hospital | Haikou | Hainan | 100021 | China |
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|
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000708352 | trilaciclib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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