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Completed

NCT Number: 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

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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Key information

Conditions

Extensive-stage Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hainan General Hospital

Haikou, Hainan, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily participate and sign informed consent;
  • must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:
  • Patients with extensive small-cell lung cancer confirmed by histology or cytology
  • Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment

Exclusion criteria

  • Patient is currently participating in other Interventional clinical studies;
  • Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.

Treatment and study plan

Trilaciclib

Drug
  • Carboplatin combined with Etoposide (ES-SCLC patients)
  • plus Topotecan (second/third line ES-SCLC patients)

Other names: Trilaciclib, carboplatin, etoposide#or Topotecan

Primary outcomes

  1. Incidence of severe neutropenia (SN)

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

    Incidence of severe neutropenia (SN)

Secondary outcomes

  1. Incidence of grade 3 and 4 hematologic toxicity

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  2. Incidence of intravenous or oral antibiotic administration in treatment

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  3. Incidence of G-CSF treatment

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  4. Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  5. Incidence of red blood cell (RBC) transfusions at or after week 5

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  6. The incidence of ESA administration in treatment

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  7. The incidence of TPO administration in treatment

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  8. The incidence of platelet transfusion

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  9. The number and frequency of all-caused chemotherapy drugs reduction

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  10. 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 )

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  11. Incidence of infectious serious adverse events

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  12. Incidence of pulmonary infection serious adverse events

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  13. The incidence of febrile neutropenia

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  14. Objective response rate

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  15. duration of response

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  16. Progression-free survival time

    Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months

  17. Disease control rate

    Time frame: during chemotherapy assessed up to 6 months

  18. verall survival

    Time frame: maximun up to 1.5 years

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Collaborators

  • G1 Therapeutics, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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