Serplulimab + Chemotherapy for Small Cell Lung Cancer

Not currently recruiting at 110 trial locations

Overseen By Nitin Ohri

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Shanghai Henlius Biotech

Disqualifiers: Mixed SCLC, Active malignancies, Severe allergy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Serplulimab (also known as HLX-10, Hansizhuang, or Zerpidio) combined with chemotherapy and radiotherapy for individuals with Limited-Stage Small Cell Lung Cancer (SCLC). The goal is to determine if adding Serplulimab enhances the effectiveness and safety of the treatment compared to chemotherapy and radiotherapy alone. Participants will receive either the experimental treatment or a placebo with standard care. Suitable candidates are those diagnosed with Limited-Stage SCLC, treatable with curative radiation, and who have not received prior treatment for this cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding serplulimab to chemotherapy is generally safe for people with small cell lung cancer. Studies found that this combination can extend patients' lives and is safe to use. Most experienced mild to moderate side effects, which could be managed, while serious side effects were less common. This suggests that combining serplulimab with chemotherapy and radiotherapy is safe and may aid in treating small cell lung cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for small cell lung cancer?

Serplulimab is unique because it combines with standard chemotherapy and radiotherapy to potentially enhance treatment for small cell lung cancer. Unlike traditional therapies that rely solely on chemotherapy agents like carboplatin or cisplatin paired with etoposide, Serplulimab is an anti-PD-1 monoclonal antibody designed to boost the immune system's ability to fight cancer cells. Researchers are excited about Serplulimab because it targets the PD-1 pathway, which can help the immune system better recognize and attack cancer, offering hope for improved outcomes in a condition that's notoriously hard to treat.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

In this trial, participants will receive either serplulimab or a placebo alongside chemotherapy and radiotherapy. Research has shown that adding serplulimab to chemotherapy can extend the lives of people with small cell lung cancer. One study found that patients who received serplulimab with their chemotherapy lived longer than those who received a placebo. Another study in real-world settings found this combination to be both effective and safe. These findings suggest that serplulimab may enhance the effectiveness of standard chemotherapy for lung cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Jinming Yu, MD

Principal Investigator

Shandong Cancer Hospital & Institute-department

Ying Cheng, MD

Principal Investigator

Jilin Provincial Tumor Hospital

Are You a Good Fit for This Trial?

This trial is for adults newly diagnosed with limited-stage small cell lung cancer who haven't had any treatment yet. They should be able to carry out daily activities, not have HIV or hepatitis, and no other cancers in the last 5 years except certain cured skin or localized cancers.

Inclusion Criteria

I have not received any treatment for my small cell lung cancer.

I have no active cancer and no history of cancer in the last 5 years, except for certain skin, bladder, prostate, cervical, or breast cancers that were treated and cured.

I can move around freely despite my symptoms.

Exclusion Criteria

I have had another type of cancer besides small cell lung cancer in the last 5 years.

I have been diagnosed with Non-Small Cell Lung Cancer.

My small cell lung cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 cycles of chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab or placebo every 3 weeks concurrently with standard thoracic radiotherapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 36 months

Extension

Participants may continue treatment with Serplulimab or placebo for up to 1 year after completion of concurrent chemoradiotherapy or until disease progression or intolerable toxicity

up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin/Cisplatin-Etoposide
• HLX10
• Prophylactic Cranial Irradiation (PCI)
• Thoracic Radiotherapy

Trial Overview The study tests if Serplulimab combined with chemotherapy and radiotherapy works better than just chemo and radiotherapy for this type of lung cancer. It's a phase III trial where patients are randomly assigned to either the drug or a placebo without knowing which one they get.

How Is the Trial Designed?

Group I: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy Experimental Treatment 4 Interventions

Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.

Group II: placebo + carboplatin/cisplatin-etoposide + radiotherapy Placebo Group 4 Interventions

Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.

HLX10 is already approved in China, European Union for the following indications:

Approved in China as Hansizhuang for:

• Microsatellite Instability-High (MSI-H) solid tumors
• Squamous non-small cell lung cancer (sqNSCLC)
• Extensive-stage small cell lung cancer (ES-SCLC)
• Esophageal squamous cell carcinoma (ESCC)

Approved in European Union as Hetronifly for:

• Extensive-stage small cell lung cancer (ES-SCLC)

Who Is Running the Clinical Trial?

Shanghai Henlius Biotech

Lead Sponsor

Trials

100

Recruited

19,200+

Dr. Jason Zhu

Shanghai Henlius Biotech

Chief Executive Officer since 2023

MBA from Yale University

Dr. Jun Zhu

Shanghai Henlius Biotech

Chief Medical Officer

MD from an unspecified institution

Published Research Related to This Trial

In a meta-analysis of 4413 patients from 8 randomized controlled trials, PD-1/PD-L1 inhibitors showed a significantly lower risk of all-grade adverse events (66.20% vs. 86.08%) and high-grade adverse events (14.26% vs. 43.53%) compared to chemotherapy, indicating a better safety profile.

While PD-1/PD-L1 inhibitors are generally safer, they are associated with a unique set of immune-related adverse events (irAEs) that can be severe, such as pneumonitis and thyroid dysfunction, which clinicians need to monitor closely to manage patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. Luo, W., Wang, Z., Tian, P., et al.[2021]

In a network meta-analysis of six clinical trials involving 3662 patients, immune checkpoint inhibitors combined with chemotherapy showed significantly improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone for extensive-stage small cell lung cancer (ES-SCLC).

Among the combinations studied, serplulimab plus chemotherapy demonstrated the best survival benefits, outperforming other combinations like ipilimumab plus chemotherapy, while both serplulimab and adebrelimab showed promising efficacy and safety profiles, although the evidence level for these comparisons is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of first-line immune checkpoint inhibitors combined with chemotherapy for extensive-stage small cell lung cancer: A network meta-analysis. Wang, S., Li, Y., Liu, Z., et al.[2023]

The combination of serplulimab and chemotherapy (etoposide and carboplatin) significantly improves survival outcomes in patients with extensive-stage small-cell lung cancer (ES-SCLC), yielding 1.217 quality-adjusted life-years (QALYs) compared to 0.885 QALYs with chemotherapy alone.

From a cost-effectiveness perspective, the combination treatment has an incremental cost-effectiveness ratio (ICER) of $12,077 per QALY, making it a cost-effective first-line option for ES-SCLC patients in China, especially for specific subgroups like former smokers and those with brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Zhu, Y., Liu, K., Qin, Q., et al.[2023]

In a phase II study involving 21 patients with PD-L1-positive advanced cervical cancer, the combination of serplulimab and nab-paclitaxel showed a promising objective response rate (ORR) of 57.1%, indicating significant efficacy in this previously treated population.

The treatment was associated with a manageable safety profile, with 81.0% of patients experiencing grade ≥3 treatment-emergent adverse events, suggesting that while the therapy is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer: a phase II, single-arm study. An, J., Li, X., Wang, J., et al.[2023]

In a meta-analysis of 14 studies, PD-1/PD-L1 inhibitors showed a significantly lower risk of treatment-related death compared to control groups, with a risk ratio of 0.37, indicating a safer profile for lung cancer patients.

While PD-1/PD-L1 inhibitors alone had a lower overall rate of adverse events compared to chemotherapy, combining them with chemotherapy increased the risk of adverse events leading to treatment discontinuation (RR = 1.68).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The overall safety evaluation of programmed cell death/programmed cell death ligand 1 (PD-1/PD-L1) treatment for lung cancer patients: An updated systematic review and meta-analysis. Shang, H., Zhang, Z., Feng, A., et al.[2022]

Serplulimab is an anti-PD-1 antibody that stimulates immune responses by counteracting PD-1-related immunosuppression, making it a promising treatment for solid tumors.

It received its first approval in China on March 25, 2022, specifically for adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that did not respond to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serplulimab: First Approval. Lee, A.[2022]

This ongoing phase II clinical trial is evaluating the combination of serplulimab with chemotherapy (etoposide and carboplatin) in 36 patients with transformed small cell lung cancer (T-SCLC) that originated from EGFR-mutant non-small cell lung cancer (NSCLC).

The primary goal of the study is to assess progression-free survival, with secondary goals including overall survival and safety, addressing the urgent need for effective treatments in this aggressive cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study. Huang, J., Zhang, XH., Cai, Y., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40440184/

First-line serplulimab plus chemotherapy in extensive ... First-line serplulimab provided a sustained clinical benefit over placebo in patients with ES-SCLC. A 15-protein signature and mutations in RB1 or Notch ...

2. henlius.com henlius.com/en/NewsDetails-5285-26.html

Latest Results of Serplulimab in Lung and Gastrointestinal ... This end-of-study analysis showed that addition of serplulimab to chemo continued to confer survival benefit to previously untreated patients with ES-SCLC ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12507603/

Effectiveness and safety of serplulimab plus platinum ... This real-world study demonstrates promising effectiveness and a manageable safety profile for the combination of serplulimab with platinum- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05353257

NCT05353257 | A Study to Evaluate the Efficacy and ... This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8093

Serplulimab versus placebo plus chemotherapy as first-line ... This end-of-study analysis showed that addition of serplulimab to chemo continued to confer survival benefit to previously untreated patients with ES-SCLC ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06554535

Efficacy and Safety of Serplulimab With Chemotherapy ... This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for ...

7. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.70322

Population Pharmacokinetics and Exposure–Response ... This study evaluated the pharmacokinetic (PK) properties of serplulimab and their relationship with efficacy and safety in patients with ...