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Extensive-stage Small-cell Lung CancerPhase 2NCT05765825

Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC

A Phase 2 study testing serplulimab, Cisplatin and Carboplatin in people with Extensive-stage Small-cell Lung Cancer, run by Sichuan University at 8 sites in China.

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 Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage… 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, Cisplatin and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
8 sitesChina
Study dates
7 Mar 2023to 31 Dec 2026
Phase
Phase 2
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

Main Inclusion Criteria:

  1. Histologically or cytologically confirmed ES-SCLC
  2. No prior treatment for ES-SCLC
  3. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
  4. ECOG performance status of 0 or 1
  5. Life expectancy >= 3 months
  6. Adequate hematologic and end-organ function
  7. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  8. Negative human immunodeficiency virus (HIV) test at screening
  9. Negative hepatitis B surface antigen (HBsAg) test at screening
  10. Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
  11. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.
  12. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
  13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Main Exclusion Criteria:

  1. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  2. Participants with pulmonary artery invasion
  3. History of leptomeningeal disease
  4. Uncontrolled tumor-related pain
  5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  6. Uncontrolled or symptomatic hypercalcemia
  7. Active or history of autoimmune disease or immune deficiency
  8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  9. Active tuberculosis
  10. Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  11. History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • China West Hospital

    Chengdu, Sichuan, 610000

  • Chongqing University cancer hospital

    Chongqing, Chongqing Municipality, 400030

  • GuiZhou Provincial People's Hospital

    Guiyang

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • LiaoNing Cancer Hospital & Institute

    Shenyang, Liaoning, 110801

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.

Read the detailed description

Enrolled patients will receive the following treatment regimen: LDRT-concurrent cisplatin/carboplatin plus etoposide in combination with serplulimab. The induction period consists of 4 cycles of 21 days each. Low-dose radiotherapy at 15Gy/5f will be performed concurrently from Day 1 to Day 5 (D1-D5) of Cycle 1. An efficacy assessment will be performed at the end of Cycle 2 and one week before the start of Cycle 3. For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage < 80%)/SD/PD, low-dose radiotherapy at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 3. For subjects evaluated as PD/SD/PR with extrathoracic residual metastases, low-dose radiotherapy at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 4. Definition of extrathoracic lesions for radiotherapy: Metastases to liver, metastases to adrenals and metastases to lymph nodes (at the discretion of the investigator).

After the induction period, the subjects will continue to receive maintenance treatment with serplulimab. Prophylactic cranial irradiation (PCI) is allowed for treatment according to local standard of care. Patients will be treated until loss of clinical benefit, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.

Being tested
serplulimab, Cisplatin, Carboplatin, Etoposide, Thoracic radiation therapy (TRT)
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.

  • serplulimabDrug

    Also called HLX10

    Serplulimab will be administered by intravenous infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.

  • CisplatinDrug

    Also called Cisplatin injection

    Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m^2) after completion of serplulimab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

  • CarboplatinDrug

    Also called Carboplatin injection

    Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

  • EtoposideDrug

    Also called Etoposide injection

    Etoposide will be administered intravenously at a dose of 100 mg/m^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

  • Thoracic radiation therapy (TRT)Radiation

    Also called low-dose radiotherapy

    Participants will receive concurrent low-dose radiotherapy treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle, third cycle（ For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage < 80%)/SD/PD），forth cycle（for subjects evaluated as PD/SD/PR with extrathoracic residual metastases).

Study groups in NCT05765825
Study groupRoleWhat they receive
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimabExperimentalParticipants will receive the following treatment regimens: The induction period consists of 4 cycles of 21 days each. Low-dose radiotherapy(LDRT) at 15Gy/5f will be performed concurrently from Day 1 to Day 5 (D1-D5) of Cycle 1. An efficacy assessment will be performed at the end of Cycle 2. For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage < 80%)/SD/PD, ldrt at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 3. For subjects evaluated as PD/SD/PR with extrathoracic residual metastases, ldrt at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 4. After the induction period, the subjects will continue to receive maintenance treatment with serplulimab.
Receives: Drug: serplulimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Radiation: Thoracic radiation therapy (TRT)

What is being measured

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

  1. Progression-free survival (PFS)

    The time from the date of first dosing of serplulimab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

    Measured: Baseline up to approximately 24 months

Secondary outcomes (6)

  1. PFS Rate at 6 Months and 1 Year

    PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to RECIST v1.1.

    Measured: Baseline up to 1 year

  2. Overall Survival (OS)

    The time from the date of first dosing of serplulimab to death from any cause.

    Measured: Baseline up to approximately 24 months

  3. OS Rate at 1 Year and 2 Years

    OS rate at 1 year and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year and 2 years.

    Measured: Baseline to 2 years or death, whichever occurs first.

  4. Duration of response (DOR)

    defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

    Measured: Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 24 months)

  5. Disease control rate (DCR)

    defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.

    Measured: Baseline up to approximately 24 months

  6. Percentage of Participants With Adverse Event

    • The incidence and severity of adverse events, with severity determined according to the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0)

    Measured: Baseline up to approximately 36 months

Timeline

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

  1. First posted13 Mar 2023
  2. Study start7 Mar 2023
  3. Primary completion31 Jul 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05765825
Sponsor's protocol ID
SPUR
Status last verified
Apr 2026
First submitted
1 Mar 2023
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing serplulimab, Cisplatin and Carboplatin in people with Extensive-stage Small-cell Lung Cancer, run by Sichuan University at 8 sites in China.

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

Who may be eligible to take part?

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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression-free survival (PFS) (time frame: Baseline up to approximately 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 NCT05765825.

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 29 Apr 2026.

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