Combining Serplulimab with Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer

A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer(LS-SCLC).

This study is testing if adding Serplulimab to standard chemotherapy and radiation can help people with limited-stage small cell lung cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: nivolumab, chemotherapy, immunotherapy, radiation, Surlidumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06295926 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Serplulimab, an immunotherapy agent, in combination with concurrent chemoradiotherapy (CCRT) for patients with limited-stage small cell lung cancer (LS-SCLC). A total of 96 treatment-naïve patients will receive four cycles of etoposide plus cisplatin/carboplatin along with thoracic radiotherapy, followed by consolidation therapy with Serplulimab until disease progression or for at least one year. The study aims to evaluate progression-free survival (PFS) and overall survival (OS) compared to those receiving CCRT alone, while also identifying biomarkers that may predict treatment efficacy. Safety and tolerability of this combination therapy will also be assessed.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed limited-stage small cell lung cancer who have not received prior treatments.

Not a fit: Patients with extensive-stage small cell lung cancer or those who have previously undergone any form of anti-tumor treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for patients with limited-stage small cell lung cancer.

How similar studies have performed: While immunotherapy has shown promise in extensive-stage small cell lung cancer, the combination with CCRT in limited-stage disease is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 years or older
2. Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging)
3. Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
4. Measurable lesions based on RECIST 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention
6. Baseline hematologic, blood biochemistry, and urine biochemistry tests confirming sufficient bone marrow and organ function
7. Life expectancy of at least 6 months
8. Male participants: Male participants must agree to use effective contraception during the study treatment and for at least 180 days after the last dose, and must not donate sperm during this period
9. Female participants must not be pregnant or lactating, and must meet at least one of the following conditions:

   1. Women who are not capable of reproduction or
   2. Agree to use effective contraception during the treatment and for at least 180 days after the last dose
   3. Women capable of reproduction must undergo a serum or urine pregnancy test within 72 hours before starting the medication, and the result must be negative (minimum sensitivity 25 IU/L or equivalent units of HCG)

(11) Signed informed consent form

Exclusion Criteria:

1. Patients with extensive-stage small cell lung cancer
2. Cancer patients who have undergone surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer
3. LS-SCLC patients with stage I disease amenable to surgical resection
4. Patients with active autoimmune diseases requiring systemic treatment (with disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
5. History of (non-infectious) pneumonia/interstitial lung disease requiring steroids or current active pneumonia/interstitial lung disease requiring steroids
6. Previously diagnosed with immunodeficiency diseases such as immunoglobulin deficiency, aplastic anemia, etc.
7. Known history of human immunodeficiency virus (HIV) infection
8. Concurrent active hepatitis B (defined as HBV DNA \> 500 copies) and hepatitis C virus (defined as HCV RNA (+)) infection
9. Known active tuberculosis history (tuberculin bacillus)
10. Receipt of live vaccine or attenuated live vaccine within 30 days prior to the first study intervention. Use of inactivated vaccines is allowed. Live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines. Injectable seasonal influenza vaccine is generally an inactivated virus vaccine and is allowed; however, intranasal influenza vaccine (e.g., FluMist®) is an attenuated live vaccine and is not allowed
11. Known other malignancy within the past 1 year that is progressing or requires active treatment. Note: Excludes adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma (excluding in situ bladder carcinoma)
12. Symptomatic central nervous system metastases and/or carcinomatous meningitis
13. Severe hypersensitivity reaction (≥3 grade) to nivolumab/platinum/etoposide and/or any of their excipients
14. Active infection requiring systemic therapy
15. Any medical condition the investigator believes would pose excessive risk to the patient. For example, poorly controlled diabetes, active infection requiring parenteral anti-infective therapy, hepatic failure, any psychiatric condition that would interfere with understanding the informed consent form (ICF). Any past or present disease, treatment, laboratory abnormality, or other condition that, in the opinion of the investigator, would confound the study results or interfere with participation throughout the study
16. Known psychiatric illness or substance abuse that would interfere with compliance with trial requirements
17. Pregnancy, lactation, planned pregnancy, or intent to become pregnant or father children during the expected duration of the study (from screening visit through 180 days after the last dose of investigational drug)
18. Prior allogeneic tissue/organ transplantation
19. Patients unable to comply with study visits
20. Currently participating in or has used other investigational drugs or devices

Where this trial is running

Beijing, Beijing Municipality

• Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Mengzhao Wang, MD — Peking Union Medical College Hospital
• Study coordinator: mengzhao Wang, MD

Conditions Small Cell Lung Cancer