Using Serplulimab after Chemoradiotherapy for Limited Stage Small Cell Lung Cancer

A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

This study is testing if the drug Serplulimab can help people with limited stage small cell lung cancer feel better after they have received chemotherapy and radiation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Serplulimab, radiation
• Locations: 2 sites (Jiamusi, Heilongjiang and 1 other locations)
• Trial ID: NCT05443646 on ClinicalTrials.gov

What this trial studies

This multi-center, single-arm Phase II study aims to evaluate the efficacy and safety of Serplulimab as a consolidation treatment following hypofractionated radiotherapy combined with chemotherapy in patients with limited stage small cell lung cancer. Eligible participants will receive up to four cycles of chemotherapy, followed by a specific radiation regimen, and those without disease progression will continue with Serplulimab infusions. The study will assess tumor response using RECIST 1.1 criteria to determine the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed limited stage small cell lung cancer and an ECOG performance status of 0-1.

Not a fit: Patients with mixed small cell lung cancer or those suitable for surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with limited stage small cell lung cancer.

How similar studies have performed: While similar approaches have been explored, this specific combination of Serplulimab with concurrent chemoradiotherapy is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years; ECOG score 0-1.
2. Histologically or cytologically confirmed small cell lung cancer.
3. Limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on PET-CT considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest CT is less than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition of AJCC staging in 2009) .
4. No other previous anti-tumor history, at least 3 months of expected survival.
5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC.
2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
4. Patients with other active malignancies within 5 years or at the same time.
5. Subjects with known history of severe allergy to any monoclonal antibody.
6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Where this trial is running

Jiamusi, Heilongjiang and 1 other locations

• Jiamusi Cancer Hospital — Jiamusi, Heilongjiang, China (Recruiting)
• Shanxi Province Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Nan Bi, Doctor — Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Nan Bi, Doctor

Conditions Limited Stage Small Cell Lung Cancer