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).
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.
Primary outcome:
1. Overall survival(OS (Time Frame - up to 36 months):
the time from randomization to death due to any cause
Secondary outcome:
1. Progression-free survival (Time Frame - up to approximately 24months):
PFS, assessed by the investigator as per RECIST v1.1
- Experimental: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first. - Placebo Comparator: placebo + carboplatin/cisplatin-etoposide + radiotherapy
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
- HLX10 (Serplulimab):
Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W - carboplatin/cisplatin-etoposide:
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. - Thoracic radiotherapy:
Standard Thoracic Radiotherapy - Placebo:
Placebo Q3W - Prophylactic Cranial Irradiation (PCI):
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Quelle: ClinicalTrials.gov
