Limited-Stage Small Cell Lung Cancer
Conditions
Keywords
Limited-Stage Small Cell Lung Cancer, Serplulimab
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+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
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 (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
Interventions
DRUGHLX10
Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice. Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
RADIATIONThoracic radiotherapy
Standard Thoracic Radiotherapy
DRUGPlacebo
Placebo Q3W
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged ≥18 years when signing the ICF. 2. Histologically diagnosed with SCLC. 3. 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. 4. Major organs are functioning well.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to approximately 24months | PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1 |
| Overall survival (OS) | up to 36 months | the time from randomization to death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to approximately 24months | PFS, assessed by the investigator as per RECIST v1.1 |
| Objective response rate (ORR) | up to approximately 24months | ORR, assessed by the BICR and investigator as per RECIST 1.1 |
| Duration of remission (DOR) | up to approximately 24months | DOR, assessed by the BICR and investigator as per RECIST 1.1 |
Countries
Austria, China, Czechia, Germany, Greece, Hungary, Latvia, Netherlands, Poland, Spain, United States
Outcome results
None listed