Clinical trial · Interventional
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
NCT05874401CI-TRIAL-00094546recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
| Trilaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
- description
- Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)
- interventionNames
- Drug: Trilaciclib
- Drug: Topotecan
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Topotecan 1.5 mg/m²
- description
- Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).
- interventionNames
- Drug: Placebo
- Drug: Topotecan
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology 2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination. 3. Measurable or evaluable disease as defined by RECIST v1.1 Exclusion Criteria: 1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC 2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer 3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids 4. Radiotherapy within 2 weeks 5. History of ILD/pneumonitis 6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
References
Publications (0)
Data not yet available
No reference posted for this study.