Serplulimab + Chemotherapy for Small Cell Lung Cancer

Not currently recruiting at 116 trial locations

Overseen By Wallace Akerley

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Shanghai Henlius Biotech

Must not be taking: Psychotropic drugs

Disqualifiers: Mixed SCLC, Severe allergy, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 14 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, Serplulimab (an experimental treatment), combined with chemotherapy for individuals with extensive-stage small cell lung cancer (ES-SCLC). It will compare this new combination to an existing treatment, Atezolizumab (an immunotherapy drug) plus the same chemotherapy. The goal is to determine which treatment is more effective for individuals who have not yet received any treatment for their ES-SCLC. Suitable candidates for this trial include those diagnosed with ES-SCLC, who have not undergone previous treatment for it, and have at least one tumor measurable by doctors. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using denosumab for bone metastases, you must switch to bisphosphonate therapy before and during the trial.

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

Research shows that Serplulimab, when combined with chemotherapy, offers promising safety results for treating small cell lung cancer. Earlier studies demonstrated that this combination provided lasting benefits and extended patient survival without causing major harm. Patients generally tolerated the treatment well, with side effects similar to other treatments in its category.

Atezolizumab, the other treatment in this trial, has FDA approval for treating various cancers, including small cell lung cancer. This approval confirms Atezolizumab's proven safety record from thorough testing in earlier studies.

Overall, both treatments in this trial have demonstrated general safety for patients, with manageable side effects. However, discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

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

Unlike the standard of care for small cell lung cancer, which typically involves drugs like atezolizumab combined with chemotherapy, Serplulimab offers a fresh approach. Serplulimab is a novel PD-1 inhibitor, which means it works by blocking a specific protein on immune cells, potentially enhancing the body's immune response against cancer cells. Researchers are excited about Serplulimab because it could provide a more effective way to engage the immune system, potentially improving outcomes for patients with this aggressive form of lung cancer.

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

Research has shown that adding Serplulimab to chemotherapy holds promise for patients with extensive-stage small-cell lung cancer (ES-SCLC). In this trial, some participants will receive Serplulimab with chemotherapy, while others will receive Atezolizumab with chemotherapy. Earlier studies found that patients who received Serplulimab with chemotherapy lived longer than those who did not. These findings suggest that this treatment could improve outcomes for patients who have not yet been treated. Additionally, Serplulimab generally has a manageable safety profile, meaning the side effects are usually tolerable. This combination could offer a new treatment option for patients with ES-SCLC. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for US patients newly diagnosed with extensive-stage small cell lung cancer (ES-SCLC) who are fully mobile and have not received prior treatment. Eligible participants must not have other active cancers, except certain cured skin or in situ cancers, and should test negative for HIV, Hepatitis B/C. They cannot join if they've had a solid organ or bone marrow transplant, cervical/bladder/skin cancer, peripheral neuropathy, or brain metastasis.

Inclusion Criteria

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.

Answer yes if you do not have HIV, Hepatitis B or Hepatitis C

I do not have brain metastasis or carcinomatous meningitis.

Exclusion Criteria

I have been diagnosed with cervical cancer.

You have been diagnosed with HIV, Hepatitis B, or Hepatitis C.

I have been newly diagnosed with extensive-stage small cell lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Serplulimab or Atezolizumab plus chemotherapy (carboplatin-etoposide)

14 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Carboplatin
• Etoposide
• HLX10

Trial Overview The study compares the efficacy and safety of two treatments: Serplulimab plus chemotherapy (carboplatin-etoposide) versus Atezolizumab plus the same chemotherapy in untreated ES-SCLC patients. Participants will be randomly assigned to either Arm A (Serplulimab group) or Arm B (Atezolizumab control group).

How Is the Trial Designed?

Group I: Serplulimab + chemotherapy Experimental Treatment 1 Intervention

Serplulimab + chemotherapy (carboplatin-etoposide)

Group II: Atezolizumab + chemotherapy Active Control 1 Intervention

Atezolizumab + chemotherapy (carboplatin-etoposide)

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 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 study evaluating the cost-effectiveness of serplulimab plus chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) in China, the treatment increased life expectancy by 0.826 years and quality-adjusted life-years (QALYs) by 0.436, but had a high incremental cost-effectiveness ratio (ICER) of $120,149/QALY, indicating it is not cost-effective at standard willingness-to-pay thresholds.

Despite showing clinical benefits and a relative safety profile, serplulimab plus chemotherapy was deemed not cost-effective for ES-SCLC patients unless the cost of serplulimab is significantly reduced, suggesting that pricing strategies could improve its economic viability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of first-line serplulimab combined with chemotherapy for extensive-stage small cell lung cancer. Liang, X., Chen, X., Li, H., et al.[2023]

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]

In a phase 3 trial involving 551 patients with advanced esophageal squamous cell carcinoma (ESCC), the combination of serplulimab (an anti-PD-1 antibody) and chemotherapy significantly improved progression-free survival (PFS) compared to placebo plus chemotherapy, with a median PFS of 5.8 months versus 5.3 months.

The same combination also significantly prolonged overall survival (OS), with a median OS of 15.3 months for serplulimab plus chemotherapy compared to 11.8 months for the placebo group, while maintaining a manageable safety profile with similar rates of severe adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial. Song, Y., Zhang, B., Xin, D., 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]

Serplulimab is projected to be a cost-effective first-line therapy for extensive-stage small-cell lung cancer in both the US and China, with an incremental cost-effectiveness ratio (ICER) of $106,757 in the US and $33,392 in China, based on a model analyzing data from 746 patients.

The study suggests that serplulimab would be cost-effective at a price below $762.11 per 100 mg in the US and below $373.37 per 100 mg in China, providing a pricing strategy that could guide decision-makers and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serplulimab Plus Chemotherapy vs Chemotherapy for Treatment of US and Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: A Cost-Effectiveness Analysis to Inform Drug Pricing. Shao, T., Zhao, M., Liang, L., et al.[2023]

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]

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]

The addition of serplulimab to chemotherapy for extensive-stage small cell lung cancer (SCLC) improved survival by 0.25 life-years and 0.15 quality-adjusted life-years (QALYs), but significantly increased treatment costs by $26,402.

The cost-effectiveness analysis revealed an incremental cost-effectiveness ratio (ICER) of $179,161 per QALY, indicating that serplulimab plus chemotherapy is not cost-effective in China, unless price discounts are applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of serplulimab as first-line therapy for extensive-stage small cell lung cancer in China. Xiang, G., Jiang, T., Gan, L., et al.[2023]

Citations

1. 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- ...

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. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04063163

Study Details | NCT04063163 | A Randomized, Double- ... Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Front Immunol. 2023 Jan 4 ...

5. 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 ...

6. 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 ...

7. 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 ...