Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trilaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trilaciclib, carboplatin, etoposide, Topotecan
- description
- Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients)
- interventionNames
- Drug: Trilaciclib
Primary outcomes (1)
- measure
- Incidence of severe neutropenia (SN)
- timeFrame
- during Trilaciclib plus chemotherapy assessed up to 6 months
- description
- Incidence of severe neutropenia (SN)
Secondary outcomes (18)
- measure
- Incidence of grade 3 and 4 hematologic toxicity
- timeFrame
- during Trilaciclib plus chemotherapy assessed up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available