Serplulimab + Chemotherapy for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+95 other locations

Overseen by Jinming Yu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Shanghai Henlius Biotech

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if adding a new drug called Serplulimab to standard treatments (chemotherapy and radiotherapy) can help patients with a specific type of lung cancer. Serplulimab aims to boost the immune system to fight cancer more effectively. Serplulimab has shown benefits when combined with chemotherapy in previous trials.

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.

What data supports the idea that Serplulimab + Chemoradiotherapy for Small Cell Lung Cancer is an effective treatment?

The available research shows that Serplulimab combined with chemotherapy is effective for treating extensive-stage small cell lung cancer (ES-SCLC). In the ASTRUM-005 trial, this combination was found to improve survival compared to chemotherapy alone. Additionally, a network meta-analysis involving multiple studies indicated that Serplulimab plus chemotherapy resulted in better overall survival and progression-free survival compared to other treatments like ipilimumab, adebrelimab, atezolizumab, and durvalumab when combined with chemotherapy. This suggests that Serplulimab + Chemoradiotherapy is a promising option for treating this type of lung cancer.

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What safety data is available for Serplulimab combined with chemoradiotherapy in treating small cell lung cancer?

The safety data for Serplulimab, an anti-PD-1 antibody, has been evaluated in various studies. It has been approved in China for treating MSI-H solid tumors, indicating a level of safety for use in humans. Meta-analyses have been conducted to assess the safety of PD-1/PD-L1 inhibitors, including Serplulimab, in lung cancer patients, showing significant survival benefits but also highlighting the need to understand the full spectrum of toxic events. A phase II trial is specifically evaluating the safety and efficacy of Serplulimab combined with chemotherapy in transformed small cell lung cancer, which may provide more specific safety data for this combination.

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Is the drug Serplulimab a promising treatment for small cell lung cancer?

Yes, Serplulimab combined with chemotherapy shows promise for treating small cell lung cancer. It has been shown to improve survival rates compared to chemotherapy alone, making it a potentially effective option for patients.

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Eligibility Criteria

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.

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site - Santa Rosa Santa Rosa, CA

Research Site - Redlands Redlands, CA

Research Site - Bloomington Bloomington, MN

Research Site - Houston (77090) Houston, TX

More Trial Locations

Who Is Running the Clinical Trial?

Shanghai Henlius Biotech Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Serplulimab: First Approval. [2022] Serplulimab (®) is an intravenously administered anti-PD-1 antibody being developed by Shanghai Henlius Biotech, Inc. for the treatment of solid tumours. Anti-PD-1 immunotherapies, such as serplulimab, can stimulate immune responses by relieving PD-1-related immunosuppression. Serplulimab received its first approval on 25 Mar 2022 in China for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) solid tumours that have failed to respond to previous standard treatments. This article summarizes the milestones in the development of serplulimab leading to this first approval in the treatment of MSI-H solid tumours in adults.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. [2023] The ASTRUM-005 trial (NCT04063163) revealed that combination serplulimab plus chemotherapy (etoposide and carboplatin [EC]) treatment was associated with survival advantages relative to chemotherapy alone in patients diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). As these immuno-chemotherapeutic regimens are extremely expensive, however, it is critical that the relative cost-effectiveness of combination serplulimab and chemotherapy treatment as a first-line treatment for ES-SCLC patients be examined in detail.

3. England 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. [2023] Transformed small cell lung cancer (T-SCLC) is a highly aggressive clinical disease with a notably poor prognosis. It most often arises from epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) following treatment. To date, no standard treatment has been established for T-SCLC. Platinum-etoposide was the most commonly used regimen, but progression-free survival remains unsatisfactory. Therefore, there is an urgent unmet need to develop novel and effective strategies for this population. Our study, a multicentre, open-label, single-arm phase II clinical trial (NCT05957510), aims to evaluate the efficacy and safety of serplulimab plus chemotherapy in untreated T-SCLC patients after histological transformation.

4. Switzerland 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. [2023] We report the efficacy and safety of serplulimab, a novel humanized anti-programmed death-1 antibody, plus nanoparticle albumin-bound (nab)-paclitaxel in previously treated patients with programmed death ligand-1 (PD-L1)-positive advanced cervical cancer.

5. Ireland 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. [2023] The efficacy and safety of first-line immune checkpoint inhibitors plus chemotherapy in the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) remains unevaluated, and there are no reports to directly compare the efficacy and safety among different immunotherapy (especially adebrelimab and surplulimab). Suitable phase III randomized controlled trials with two or more different arms were included. Independent reviewers screened and extracted relevant data and disagreements were resolved through consensus. Fixed-effect consistency models were used to calculate the overall survival (OS), progression-free survival (PFS), objective response rate, adverse events ≥ 3, and safety outcomes in the clinically relevant subgroups. In this network meta-analysis, six randomized controlled clinical trials (CAPSTONE-1, ASTRUM-005, CASPIAN, IMpower133, KEYNOTE-604, and an ipilimumab + chemotherapy trial) with totaling 3662 patients were involved. Compared to chemotherapy, immune checkpoint inhibitors plus chemotherapy present higher possibilities to bring about better OS and PFS. Serplulimab + chemotherapy significantly showed a better survival profit in comparison with ipilimumab + chemotherapy (0.67; 0.50-0.90). Compared with chemotherapy, adebrelimab + chemotherapy (0.72; 0,58-0.90), atezolizumab + chemotherapy (0.76; 0.60-0.96) durvalumab + chemotherapy (0.75; 0.62-0.91), and serplulimab + chemotherapy (0.63;0.49-0.82) all presented significantly better overall survival. In terms of progression-free survival, serplulimab + chemotherapy showed better efficacy in comparison with adebrelimab + chemotherapy (0.72; 0,53-0.97), atezolizumab + chemotherapy (0.62; 0.46-0.84), durvalumab + chemotherapy (0.60; 0.45-0.80). Compared with chemotherapy, adebrelimab + chemotherapy (0.67; 0.54-0.83) and serplulimab + chemotherapy (0.48; 0.48-0.86) all presented significantly better PFS. Immunotherapy plus chemotherapy had similar probabilities to cause adverse events of grade ≥ 3. In comparison with chemotherapy, immune checkpoint inhibitors plus chemotherapy were likely to be more suitable for the first-line treatment of ES-SCLC. According to our analysis, serplulimab plus chemotherapy and adebrelimab plus chemotherapy present higher possibilities to show better efficacy and safety, however, the level of evidence of this type of comparison is limited.

6. Germany 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. [2021] Significant improvement in survival outcome with the programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors has been shown in advanced non-small cell lung cancer (NSCLC) patients compared with chemotherapy. However, the full spectrum of toxic events of PD-1/PD-L1 inhibitors was not well characterized. We conducted a comprehensive meta-analysis to state the safety profile of PD-1/PD-L1 inhibitors in NSCLC, and identify the exact incidence and relative risk (RR) of both summary and detailed AEs.

7. United States 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. [2022] We performed the meta-analysis to evaluate the overall safety of programmed cell death-1 (PD-1) or ligand 1 (PD-L1) inhibitor treatment for lung cancer patients.