Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Limited-Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ conc...
Detailed Description
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio. Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B ...
Eligibility Criteria
Inclusion
- Male or female, aged ≥18 years when signing the ICF.
- Histologically diagnosed with SCLC.
- Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
- Major organs are functioning well.
Exclusion
- Histologically or cytologically confirmed mixed SCLC.
- Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
- Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
- Patients with other active malignancies within 5 years or at the same time.
- Subjects with known history of severe allergy to any monoclonal antibody.
- Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
- In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT05353257
Start Date
May 17 2022
End Date
December 30 2026
Last Update
January 28 2025
Active Locations (129)
Enter a location and click search to find clinical trials sorted by distance.
1
OPN-Glendale
Arcadia, California, United States, 91007
2
OPN-Los Alamitos
Los Alamitos, California, United States, 90720
3
Southern California Permanente Group
Los Angeles, California, United States, 90034
4
Emad Ibrahim, MD, Inc
Redlands, California, United States, 92373