Clinical trial · Interventional
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)
- 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 randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab + chemotherapy (carboplatin-etoposide) | Drug | — | UNRESOLVED |
| Serplulimab + chemotherapy (carboplatin-etoposide) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Serplulimab + chemotherapy
- description
- Serplulimab + chemotherapy (carboplatin-etoposide)
- interventionNames
- Drug: Serplulimab + chemotherapy (carboplatin-etoposide)
- type
- ACTIVE_COMPARATOR
- label
- Atezolizumab + chemotherapy
- description
- Atezolizumab + chemotherapy (carboplatin-etoposide)
- interventionNames
- Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)
Primary outcomes (1)
- measure
- OS
- timeFrame
- A period from randomization through death regardless of causality (approximately up to 24 months).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Voluntary participation in clinical studies. Male or female aged ≥ 18 years at the time of signing the ICF. Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system). No prior systemic therapy for ES-SCLC. At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization. Major organs are functioning well. Every effort should be made to provide tumor tissues for the determination of PD-L1 expression. An ECOG PS score of 0 or 1. An expected survival ≥ 12 weeks. Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment. Participant must keep contraception. Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC. Known history of severe allergy to any monoclonal antibody. Known hypersensitivity to carboplatin or etoposide. Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia. Pregnant or breastfeeding females. Patients with a known history of psychotropic drug abuse or drug addiction. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
References
Publications (0)
Data not yet available