Extensive Stage Small Cell Lung CancerPhase 3NCT04063163
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
A Phase 3 study testing HLX10 and carboplatin and etoposide in people with Extensive Stage Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 5 sites in 5 countries.
Trial summary
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer. 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?
- HLX10 and carboplatin and etoposide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 585 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 12 Sep 2019to 7 May 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- No prior systemic therapy for ES-SCLC
- Major organs are functioning well
- 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.
- 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
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)
Read the detailed description
After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- HLX10, carboplatin and etoposide, placebo
- Keywords
- Extensive Stage, Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX10Drug
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
carboplatin and etoposideDrug
chemotherapeutics
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | HLX 10+chemotherapy (Carboplatin-Etoposide) Receives: Drug: HLX10; Drug: carboplatin and etoposide |
| B | Placebo comparator | Placebo+chemotherapy (Carboplatin-Etoposide) Receives: Drug: carboplatin and etoposide; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS)
Measured: The period from randomization through death regardless of causality (up to approximately 56 months)
Secondary outcomes (3)
Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1
PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first).
Measured: From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).
Objective Response Rate
The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE.
Measured: From baseline until PR or CR, whichever occurs first (up to approximately 56 months)
Duration of Response
DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first).
Measured: From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start12 Sep 2019
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063163
- Sponsor's protocol ID
- HLX10-005-SCLC301
- Status last verified
- Dec 2025
- First submitted
- 17 Aug 2019
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Shi J, Pan Z, Shi J, Wang X, Bai Y, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Yu H, Li J, Yang X, Wang Q, Zhu J; ASTRUM-005 Study Group. First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Jun 4:e261645. doi: 10.1001/jamaoncol.2026.1645. Online ahead of print.
PubMed 42240984Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
PubMed 40932107Zhu Y, Liu K, Qin Q, Zhu H. Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Front Immunol. 2023 Jan 4;13:1044678. doi: 10.3389/fimmu.2022.1044678. eCollection 2022.
PubMed 36685541Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.
PubMed 36166026
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC
- ClinicalTrials.gov ID
- NCT04063163
- Acronym / sponsor ID
- HLX10-005-SCLC301
- 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
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Posted 9 Dec 2025
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, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)
Detailed description
After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: HLX10, Drug: carboplatin and etoposideHLX 10+chemotherapy (Carboplatin-Etoposide) |
| B | Placebo comparator | Drug: carboplatin and etoposide, Drug: placeboPlacebo+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 (4 listed)
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- No prior systemic therapy for ES-SCLC
- Major organs are functioning well
- Participant must keep contraception
Key exclusion criteria (6 listed)
- Histologically or cytologically confirmed mixed SCLC.
- Known history of severe allergy to any monoclonal antibody.
- Known hypersensitivity to carboplatin or etoposide.
- Pregnant or breastfeeding females.
- Patients with a known history of psychotropic drug abuse or drug addiction.
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 |
|---|---|---|
| HLX10HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. | Drug | A |
| carboplatin and etoposidechemotherapeutics | Drug | A, B |
| placeboplacebo | Drug | B |
Primary outcome
OS
Time frame: The period from randomization through death regardless of causality (up to approximately 56 months)
Overall survival (OS)
3 secondary outcomes
Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1
Time frame: From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).
Objective Response Rate
Time frame: From baseline until PR or CR, whichever occurs first (up to approximately 56 months)
Duration of Response
Time frame: From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42240984Liu J, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Shi J, Pan Z, Shi J, Wang X, Bai Y, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Yu H, Li J, Yang X, Wang Q, Zhu J; ASTRUM-005 Study Group. First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Jun 4:e261645. doi: 10.1001/jamaoncol.2026.1645. Online ahead of print.
- Derived from this study: PubMed 40932107Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
- Derived from this study: PubMed 36685541Zhu Y, Liu K, Qin Q, Zhu H. Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Front Immunol. 2023 Jan 4;13:1044678. doi: 10.3389/fimmu.2022.1044678. eCollection 2022.
- Derived from this study: PubMed 36166026Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.
- Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HLX10 and carboplatin and etoposide in people with Extensive Stage Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 5 sites in 5 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Georgia, Poland, Russia, Turkey (Türkiye), Ukraine. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: The period from randomization through death regardless of causality (up to approximately 56 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 NCT04063163, which also lists 4 linked publications.
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 9 Dec 2025.