Who is eligible for clinical trial NCT05468489?

Participants must meet the protocol's inclusion criteria for Extensive Stage Small Cell Lung Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05468489 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-20

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC (NCT05468489)

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)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Shanghai Henlius Biotech

🩺 Plain-English Summary (8th-Grade Level)

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)

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (1 items).

Location: Alabama Oncology — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (67 Sites)

Showing the first 25 of 67 sites.

Alabama Oncology — Birmingham, Alabama
City of Hope - Phoenix — Goodyear, Arizona
Arizona Clinical Research Center (ACRC) — Tucson, Arizona
Highlands Oncology Group — Springdale, Arkansas
Compassionate Care Research Group — Fountain Valley, California
Providence Medical Foundation — Fullerton, California
Los Angeles Cancer Network — Glendale, California
OPN - Oncology Physician Network — Los Alamitos, California
Kaiser Permanente Research (Southern California) — Los Angeles, California
UC Davis — Sacramento, California
UCHealth Memorial Hospital North — Colorado Springs, Colorado
Banner MD Anderson Cancer Center (BMDACC) — Greeley, Colorado
MD Anderson- North Colorado Medical Center — Greeley, Colorado
Advanced Cancer Treatment Centers — Brooksville, Florida
Cancer Specialists North Florida — Jacksonville, Florida
Mount Sinai Comprehensive Cancer Center — Miami, Florida
Florida Cancer Affiliates- (Ocala Oncology - Main) — Ocala, Florida
Mid Florida Hematology and Oncology Center — Orange City, Florida
BRCR Global — Plantation, Florida
Napa Research — Pompano Beach, Florida
Advanced Research — Tamarac, Florida
City of Hope- Chicago — Chicago, Illinois
Cancer Center of Decatur — Decatur, Illinois
Accellacare of Duly — Tinley Park, Illinois
Northwest Cancer Centers — Dyer, Indiana

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Extensive Stage Small Cell Lung Cancer

A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab — Orlando, Florida
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC) — Los Angeles, California
Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer — Chicago, Illinois
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) — Los Angeles, California
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311) — Gilbert, Arizona

Explore by condition: All Extensive Stage Small Cell Lung Cancer clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗