Extensive Stage Small Cell Lung CancerPhase 3NCT05468489

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

A Phase 3 study testing Serplulimab + chemotherapy (carboplatin-etoposide) and Atezolizumab + chemotherapy (carboplatin-etoposide) in people with Extensive Stage Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 67 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Extensive Stage Small Cell Lung Cancer
What is being tested?: Serplulimab + chemotherapy (carboplatin-etoposide) and Atezolizumab + chemotherapy (carboplatin-etoposide)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 67 sitesUnited States
Study dates: 18 Nov 2022to 31 Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 11Show fewer

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.

Who cannot join

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.

Trial locations and contacts

67 sites in 1 country.

City, postcode or hospital

67 sites in 1 country

United States67 sites

Summa Health
Akron, Ohio, 44304
CHRISTUS St. Frances Cabrini Cancer Center
Alexandria, Louisiana, 71301
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
Alabama Oncology
Birmingham, Alabama, 35223
Advanced Cancer Treatment Centers
Brooksville, Florida, 34613
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Aultman Cancer Center
Canton, Ohio, 44710
City of Hope- Chicago
Chicago, Illinois, 60099
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UCHealth Memorial Hospital North
Colorado Springs, Colorado, 80920
CHRISTUS Institute for Innovation & Advanced Clinical Care
Corpus Christi, Texas, 78404
Cancer Center of Decatur
Decatur, Illinois, 62526
Northwest Cancer Centers
Dyer, Indiana, 46311
DHR Research
Edinburg, Texas, 78539
Elmhurst (BRANY site)
Elmhurst, New York, 11373
Compassionate Care Research Group
Fountain Valley, California, 92708
Regional Cancer Care Associates LLC RCCA
Freehold, New Jersey, 03756
Providence Medical Foundation
Fullerton, California, 92835
Los Angeles Cancer Network
Glendale, California, 91204
City of Hope - Phoenix
Goodyear, Arizona, 85338
Banner MD Anderson Cancer Center (BMDACC)
Greeley, Colorado, 80631
MD Anderson- North Colorado Medical Center
Greeley, Colorado, 80631
Pontchartrain Cancer Center
Hammond, Louisiana, 70433
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401
Millennium Research and Clinical Development
Houston, Texas, 77090
Cancer Specialists North Florida
Jacksonville, Florida, 32256
MidAmerica Division Inc., c/o Research Medical Center
Kansas City, Missouri, 64132
Lumi Research
Kingwood, Texas, 77339
Northwell Health
Lake Success, New York, 11042
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Baptist Health Lexington
Lexington, Kentucky, 40503
OPN - Oncology Physician Network
Los Alamitos, California, 90720
Kaiser Permanente Research (Southern California)
Los Angeles, California, 90034
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Tricounty Hematology and Oncology Associates
Massillon, Ohio, 44646
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
Froedtert Hospital- Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University Cancer Institute
Morgantown, West Virginia, 26505
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Florida Cancer Affiliates- (Ocala Oncology - Main)
Ocala, Florida, 34473
American Oncology Network Vista Oncology Division
Olympia, Washington, 98502
University of Nebraska Medical Center
Omaha, Nebraska, 68106
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Lake Regional
Osage Beach, Missouri, 65065
Pikeville Hospital
Pikeville, Kentucky, 41501
BRCR Global
Plantation, Florida, 33322
Napa Research
Pompano Beach, Florida, 33064
CharterCARE (Roger Williams)
Providence, Rhode Island, 02908
Monument Health
Rapid City, South Dakota, 57701
Renown Health
Reno, Nevada, 89502
UC Davis
Sacramento, California, 95817
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075
Highlands Oncology Group
Springdale, Arkansas, 72762
Stony Brook Cancer Center
Stony Brook, New York, 11794
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Advanced Research
Tamarac, Florida, 33321
Accellacare of Duly
Tinley Park, Illinois, 60487
Arizona Clinical Research Center (ACRC)
Tucson, Arizona, 85715
North Mississippi Medical Center Hematology and Oncology Clinic
Tupelo, Mississippi, 38801
The University of Texas Health Science Center at Tyler/HOPE Cancer Center
Tyler, Texas, 75701
Cancer Center of Kansas
Wichita, Kansas, 67214
Great Lakes Cancer Care (Kaleida Health)
Williamsville, New York, 14221

Other trials in United States

About this study

Official title: 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)

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: Extensive Stage Small Cell Lung Cancer
Being tested: Serplulimab + chemotherapy (carboplatin-etoposide), Atezolizumab + chemotherapy (carboplatin-etoposide)
Keywords: Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Serplulimab + chemotherapy (carboplatin-etoposide)Drug
Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Drug: carboplatin and etoposide chemotherapeutics
Atezolizumab + chemotherapy (carboplatin-etoposide)Drug
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG.
Drug: carboplatin and etoposide chemotherapeutics

Study groups in NCT05468489
Study group	Role	What they receive
Serplulimab + chemotherapy	Experimental	Serplulimab + chemotherapy (carboplatin-etoposide) Receives: Drug: Serplulimab + chemotherapy (carboplatin-etoposide)
Atezolizumab + chemotherapy	Active comparator	Atezolizumab + chemotherapy (carboplatin-etoposide) Receives: Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

What is being measured

The primary outcome is the main question the study is designed to answer.

OS
Overall assessment
Measured: A period from randomization through death regardless of causality (approximately up to 24 months).

Secondary outcomes (6)

ORR
Objective response rate
Measured: approximately up to 14 months
PFS
Progression-free survival
Measured: approximately up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0
Measured: approximately up to 24 months
Maximum Plasma Concentration (Cmax)
The maximum concentration (Cmax) of Serplulimab will be measured
Measured: approximately up to 24 months
Minimum Plasma Concentration (Cmin)
The minimum concentration (Cmin) of Serplulimab will be measured
Measured: approximately up to 24 months
Average Plasma Concentration (Cavg)
The average Plasma Concentration (Cavg) of Serplulimab will be measured
Measured: approximately up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202231 Dec 2027

First posted21 Jul 2022
Study start18 Nov 2022
Primary completion28 Feb 2026 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05468489
Sponsor's protocol ID: ASTRIDE (HLX10-005-SCLC301-E)
Status last verified: Oct 2025
First submitted: 11 Jul 2022
Last updated: 21 Oct 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage

All Extensive Stage Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05468489
Acronym / sponsor ID: ASTRIDE (HLX10-005-SCLC301-E)
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
Study start: 18 Nov 2022 (actual)
Primary completion: 28 Feb 2026 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 21 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Serplulimab + chemotherapy	Experimental	Drug: Serplulimab + chemotherapy (carboplatin-etoposide)Serplulimab + chemotherapy (carboplatin-etoposide)
Atezolizumab + chemotherapy	Active comparator	Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)Atezolizumab + chemotherapy (carboplatin-etoposide)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Serplulimab + chemotherapy (carboplatin-etoposide)Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics	Drug	Serplulimab + chemotherapy
Atezolizumab + chemotherapy (carboplatin-etoposide)Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics	Drug	Atezolizumab + chemotherapy

Primary outcome

OS
Time frame: A period from randomization through death regardless of causality (approximately up to 24 months).
Overall assessment

6 secondary outcomes

ORR
Time frame: approximately up to 14 months
PFS
Time frame: approximately up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: approximately up to 24 months
Maximum Plasma Concentration (Cmax)
Time frame: approximately up to 24 months
Minimum Plasma Concentration (Cmin)
Time frame: approximately up to 24 months
Average Plasma Concentration (Cavg)
Time frame: approximately up to 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Individual participant dataSharing planned: No

Related trials for Extensive Stage Small Cell Lung Cancer

Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

67 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: A period from randomization through death regardless of causality (approximately up to 24 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05468489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.