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Evaluating Serplulimab with Chemotherapy for Extensive Stage Small Cell Lung Cancer

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)

PHASE3 · Shanghai Henlius Biotech · NCT05468489

This study is testing whether a new drug called Serplulimab, when combined with chemotherapy, can help people with extensive stage small cell lung cancer feel better compared to a different treatment they would normally receive.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorShanghai Henlius Biotech (industry)
Drugs / interventionsdenosumab, Serplulimab, Atezolizumab, chemotherapy
Locations99 sites (Birmingham, Alabama and 98 other locations)
Trial IDNCT05468489 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, open-label study comparing the efficacy and safety of Serplulimab combined with chemotherapy (Carboplatin-Etoposide) against Atezolizumab with the same chemotherapy regimen in previously untreated patients with extensive stage small cell lung cancer (ES-SCLC). Participants will be randomly assigned to one of two treatment arms at a 1:1 ratio. The study aims to assess the effectiveness of Serplulimab in improving patient outcomes compared to the standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of extensive stage small cell lung cancer who have not received prior systemic therapy.

Not a fit: Patients with mixed small cell lung cancer or known allergies to the study medications may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with extensive stage small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 98 other locations

+49 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.