Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jun 29, 2022

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ClinConnect Summary

This clinical trial is studying the use of a medication called Serplulimab after patients with Limited Stage Small Cell Lung Cancer (LS-SCLC) have completed a combination of chemotherapy and radiation therapy. The goal is to see if this treatment can help improve the effectiveness of the initial therapies and keep the cancer from coming back. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with LS-SCLC and have not received other anti-cancer treatments before. Eligible participants should be in relatively good health, with no serious organ issues.

If you or a loved one qualifies for this study, you can expect to receive the Serplulimab treatment after completing standard chemotherapy and radiation. The trial is designed to monitor both the safety of this new treatment and how well it works over time. It's important to know that participants will be closely watched during the study, and they will not be able to have certain other treatments for cancer while taking part. This study could offer a potential new option for those facing this challenging type of lung cancer.

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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.