Serplulimab + Chemotherapy for Small Cell Lung Cancer
What You Need to Know Before You Apply
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.
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.
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.12345
Is the combination of Serplulimab and Chemoradiotherapy safe for humans?
Serplulimab, an anti-PD-1 antibody, has been approved for use in certain solid tumors and has been studied for safety in various cancers, including lung cancer. While specific safety data for the combination with chemoradiotherapy in small cell lung cancer is not detailed, PD-1 inhibitors like Serplulimab have been generally evaluated for safety in lung cancer patients.12345
Is the drug Serplulimab a promising treatment for small cell lung cancer?
What makes the drug Serplulimab unique for treating small cell lung cancer?
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.12367
What data supports the effectiveness of the drug Serplulimab combined with chemotherapy for treating small cell lung cancer?
Research shows that combining Serplulimab with chemotherapy can improve survival rates in patients with extensive-stage small cell lung cancer compared to chemotherapy alone. This combination has been shown to provide better overall survival and progression-free survival, making it a promising first-line treatment option.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 cycles of chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab or placebo every 3 weeks concurrently with standard thoracic radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin/Cisplatin-Etoposide
- HLX10
- Prophylactic Cranial Irradiation (PCI)
- Thoracic Radiotherapy
HLX10 is already approved in China, European Union for the following indications:
- 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)
- Extensive-stage small cell lung cancer (ES-SCLC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Henlius Biotech
Lead Sponsor
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