Study on Serplulimab with Chemotherapy and Radiotherapy for Limited-Stage Small Cell Lung Cancer
Sponsor: Shanghai Henlius Biotech
ClinicalTrials ID:NCT05353257
This clinical trial is testing the effectiveness and safety of adding Serplulimab to standard chemotherapy and radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC).
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effectiveness and safety of a new treatment combination that includes Serplulimab, chemotherapy, and radiotherapy against the standard treatment of chemotherapy and radiotherapy alone in patients with limited-stage small cell lung cancer (LS-SCLC). Participants will be randomly assigned to one of two groups: one receiving Serplulimab with chemotherapy and radiotherapy, and the other receiving a placebo with chemotherapy and radiotherapy.
Description
Participants in this study will be divided into two groups. One group will receive Serplulimab along with chemotherapy drugs (Carboplatin or Cisplatin and Etoposide) and radiotherapy. The other group will receive a placebo instead of Serplulimab, along with the same chemotherapy and radiotherapy. The study will consider factors like the patient's overall health, cancer stage, radiation schedule, and geographic region when assigning participants to groups.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with small cell lung cancer (SCLC).
- Cancer is in a limited stage (stage I-III) and can be treated with radiation.
- Major organs are functioning well.
Exclusion Criteria
- Have a mixed type of small cell lung cancer.
- Are suitable for surgery, unless they choose not to have surgery.
- Have received previous treatments for small cell lung cancer, such as chemotherapy, radiotherapy, or immunotherapy.
- Have another active cancer within the last 5 years.
- Have a history of severe allergies to monoclonal antibodies.
- Have known allergies to chemotherapy drugs carboplatin, cisplatin, or etoposide.
- Have any other conditions that might cause them to leave the study early, as judged by the investigator.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| OPN-Glendale | 91007 | Arcadia | California |
| OPN-Los Alamitos | 90720 | Los Alamitos | California |
| Southern California Permanente Group | 90034 | Los Angeles | California |
| Emad Ibrahim, MD, Inc | 92373 | Redlands | California |
| Providence Medical Foundation | 95403 | Santa Rosa | California |
| Lutheran Medical Center - Cancer Centers of Colorado | 80401 | Golden | Colorado |
| Eastern Connecticut Hematology & Oncology Associates | 06360 | Norwich | Connecticut |
| Cancer Specialists of North Florida | 32257 | Jacksonville | Florida |
| Mid Florida Hematology and Oncology Center | 32763 | Orange City | Florida |
| Advent Health Orlando | 32804 | Orlando | Florida |
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