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SCLC, Limited StagePhase 2NCT06911606

Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)

A Phase 2 study testing 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin in people with SCLC, Limited Stage, run by Guangdong Provincial People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
SCLC, Limited Stage
What is being tested?
4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
22 May 2024to 30 Jun 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in clinical research and sign written informed consent
  • Male or female patients aged 18-75 years old (including the critical value)
  • Histologically or cytologically confirmed SCLC
  • Clinically diagnosed as IIB-IIIB ( N2) stage (AJCC 8th edition cancer staging)
  • Patients who have not received systemic anti-tumor treatment or chest radiotherapy in the past
  • By Surgeons evaluate patients who have no contraindications to surgery
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  • According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there is at least one radiologically measurable lesion
  • ECOG score 0-1
  • Expected survival time > 6 months
  • Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), the hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be <2500 copies/mL or 500 IU/mL before inclusion. Subjects who are HCV antibody (-) or HCV-RNA negative can be enrolled if HCV-RNA is positive, the subject must have alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ Only 3×ULN can join the group. Subjects who are co-infected with hepatitis B and hepatitis C need to be excluded (positive HBsAg or HBcAb test, and positive HCV antibody test)
  • Laboratory tests within 7 days before the first use of the study drug confirm sufficient organ and bone marrow function, No serious hematopoietic abnormalities, cardiac, liver, renal dysfunction or immune deficiency (no blood transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factor (CSF) treatment within 14 days before the first medication in this study)
  • Female patients must meet one of the following conditions: a. Menopause (defined as the absence of menstruation for at least 1 year without other confirmed reasons other than menopause), or b. Have undergone surgical sterilization (removal of ovaries and/or uterus) , or c. Have childbearing potential, but must meet the following requirements: the serum/urine pregnancy test within 7 days before enrollment must be negative, and agree to use contraceptive measures with an annual failure rate of <1% or maintain abstinence (avoiding heterosexual intercourse) (from signing ICF to at least 6 months after the last dose of study drug) (contraceptive methods with annual failure rates <1% include bilateral fallopian tube ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, and hormone-releasing intrauterine contraception devices and copper-containing IUDs or condoms), and you must not breastfeed.
  • Male patients must meet the following requirements: Agree to abstain from sex (avoid heterosexual intercourse) or take contraceptive measures, as follows: When the partner is a female of childbearing age or the partner is pregnant, the male patient must agree to abstain from sexual intercourse (avoiding heterosexual intercourse) or take contraceptive measures for at least 6 months during the study treatment period and after the last dose of the study drug. Maintain abstinence or use condoms during the first trimester to prevent embryonic drug exposure. Periodic abstinence (for example, calendar days, ovulation period, basal body temperature or post-ovulation contraceptive method) and in vitro ejaculation are unqualified contraceptive methods
  • The end of previous non-systemic anti-tumor treatment must be ≥ 2 weeks from the start of medication, and according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0, treatment-related AEs reverted to grade ≤1 (except grade 2 alopecia).

Who cannot join

  • Mixed SCLC confirmed by histology or cytology
  • Previously received systemic anti-tumor treatment for small cell lung cancer, including but not limited to chemotherapy, immunotherapy, and radiotherapy
  • Other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, can be enrolled
  • Those who are planning to undergo or have received organs in the past or bone marrow transplant patients
  • Pleural effusion, pericardial effusion or ascites requiring clinical intervention
  • Myocardial infarction or poorly controlled arrhythmia (including men with QTc interval) within 6 months before the first administration of the study drug ≥450 ms, women ≥470 ms) (QTc interval is calculated by Fridericia's formula)
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  • The subject has uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or Corrected serum calcium > ULN)
  • The patient has grade ≥ 2 CTCAE peripheral neuropathy
  • Human immunodeficiency virus (HIV) infection, HIV antibody test results are positive
  • Suffering from active pulmonary tuberculosis
  • Past and There are currently subjects with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc. who are judged by the researcher to be likely to interfere with the detection and treatment of suspected drug-related pulmonary toxicity
  • Hepatitis B (HBsAg or HBcAb test is positive, and HBV-DNA test is positive), Hepatitis C (HCV antibody test is positive, and HCV-RNA test is positive). Subjects with co-infection of hepatitis B and hepatitis C (positive HBsAg or HBcAb test, and positive HCV antibody test). Note: Hepatitis B patients who have been stabilized by antiviral treatment (HBV-DNA ≤ 2500 copies/mL or 500IU/mL) can be enrolled
  • Subjects have known active or suspected autoimmune diseases. Subjects who are in stable condition and do not require systemic immunosuppressant treatment are allowed to enroll
  • Those who have received live vaccine treatment within 28 days before the first dose. However, inactivated viral vaccines are allowed to treat seasonal influenza, but intranasal live attenuated influenza vaccines are not allowed
  • Systemic corticosteroids (> 10 mg/ subjects treated with prednisone effective doses) or other immunosuppressive drugs. However, the following conditions are allowed: in the absence of active autoimmune disease, subjects are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at a dose of ≤ 10 mg/day prednisone effective dose
  • Any active infection requiring systemic anti-infectious therapy within 14 days before study drug administration, or the subject has a positive RT-PCR test for SARS-CoV-2 infection at enrollment. Subjects with a history of COVID-19 infection must have a negative RT-PCR test before the first administration of the study drug
  • Have undergone major surgery within 28 days before the first administration of the study drug. The definition of major surgery in this study: at least 3 weeks of recovery time are required after surgery before the surgery can be treated in this study
  • The subject has previously received other antibodies/drugs targeting immune checkpoints, such as PD-1, PD -L1, CTLA-4 and other treatments
  • Are participating in other interventional clinical studies, or plan to start treatment in this study less than 28 days from the end of treatment in a previous interventional clinical study
  • Known to have a risk for any monoclonal antibody History of severe allergies
  • Known allergic reaction to carboplatin/cisplatin or etoposide components
  • Pregnant or lactating women
  • Subjects known to have a history of psychotropic drug abuse or drug use
  • According to the researcher's judgment, the subject has other factors that may cause the study to be terminated early.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chen Huang, MD contact

+8616620159730

jeromehuang1997@163.com

China1 site, 1 recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Huang, +86 16620159730, huangchen@gdph.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective Phase II Clinical Study of Serplulimab Combined With Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC) Followed by Surgery or Radiotherapy

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC

Being tested
4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin
Keywords
II-IIIB (N2) LS-SCLC

What participants receive

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

  • 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatinDrug

    Also called surgery

    After 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy

Study groups in NCT06911606
Study groupRoleWhat they receive
4 cycles of Serplulima plus platinum-containing dual drugExperimentalAfter 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy
Receives: Drug: 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin

What is being measured

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

  1. pathological complete response rate

    The proportion of residual tumor cells evaluated under the microscope by the pathologist

    Measured: Within 2 weeks after radical surgery

Secondary outcomes (3)

  1. Objective response rate

    Measured according to RECIST1.1 evaluation criteria

    Measured: Once every 2 cycles(each cycle is 21 days) during the combined treatment phase

  2. Event-free survival

    Assess whether the lesion is operable and measure the progression of the lesion according to the RECIST1.1 assessment criteria

    Measured: Follow-up at the end of cycle 2(each cycle is 28 days), 3 to 5 weeks after the last chemotherapy, 30 days after surgery, every 3 months within two years from enrollment or until death

  3. Overall survival

    Lesions were measured according to RECIST1.1 evaluation criteria

    Measured: Follow-up every 3 months and every 6 months within two years from enrollment or until death

Timeline

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

  1. First posted4 Apr 2025
  2. Study start22 May 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911606
Sponsor's protocol ID
HLX10IIT110
Other IDs
HLX10IIT110
Status last verified
Mar 2025
First submitted
10 Mar 2025
Last updated
4 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin in people with SCLC, Limited Stage, run by Guangdong Provincial People's Hospital at 1 site in China.

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 14 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Chen Huang, MD (+8616620159730, jeromehuang1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological complete response rate (time frame: Within 2 weeks after radical surgery). 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 NCT06911606.

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 4 Apr 2025.

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