Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC) at stage I-III of the AJCC 8th edition of the cancer staging MedDRA version: 21.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Recombinant humanized anti-PD-1 monoclonal antibody, or Serplulimab
Product Code: HLX10
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Serplulimab
CAS Nu
Sponsors
Shanghai Henlius Biotech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate in this clinical study; fully understand and have been informed about the study and have signed the ICF; are willing to follow and able to complete all trial procedures. 2. Male or female, aged =18 years when signing the ICF. 3. Histologically diagnosed with SCLC. 4. Diagnosed with LS-SCLC (stage 1-3 of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses. 5. With at least one measurable lesion as assessed by investigator as per RECIST v1.1 within 4 weeks prior to randomization. 6. Patients must provide tumor tissues that meet the requirements for assay of PDL1 expression level. Patients are assessed for an evaluable PD-L1 expression category (negative: TPS =65 years) yes F.1.3.1 Number of subjects for this age range 193
Exclusion criteria
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. Localized tumors that have been cured such as basal cell carcinoma, squamouscell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ are acceptable. 5. Patients who are preparing for or have received an organ or bone marrow transplant. 6. Patients with pleural, pericardial effusions, or ascites requiring clinical intervention. 7. Patients with myocardial infarction and poorly controlled arrhythmia (including QTc intervals = 470 ms) (QTc intervals are calculated by Fridericia's formula) within 6 months prior to the first dose of the investigational products. 8. Class III to IV cardiac insufficiency according to NYHA classification or an left ventricular ejection fraction 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN). 10. Patients with peripheral neuropathy = grade 2 by CTCAE. 11. Patients with human immunodeficiency virus (HIV) infection, and HIV antibody test results are positive. 12. Patients with active pulmonary tuberculosis. 13. Subjects with previous and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity as judged by the investigator. 14. With Hepatitis B (positive test for HBsAg or HBcAb and positive test for HBVDNA) or Hepatitis C (positive tests for HCV antibody and HCV-RNA). Subjects with a co-infection of hepatitis B and hepatitis C (tested positive for HBsAg or HBcAb, and positive for anti-HCV antibody). Note: Subjects with hepatitis B who are stable on antiviral therapy (HBV-DNA=2500 copies/mL or 500IU/mL) can be enrolled. 15. Subjects with known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to be enrolled. 16. Have received treatment with live vaccines within 28 days prior to the first administration. Subjects may receive inactivated viral vaccines for seasonal influenza, but may not receive live attenuated influenza vaccines via intranasal route. 17. Subjects requiring treatment with systemic corticosteroids (> 10 mg/day therapeutic dose of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, subjects are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, subjects are allowed to use topical or inhaled glucocorticoids and = 10 mg/day therapeutic dose of prednisone for adrenal glucocorticoid replacement therapy. 18. With any active infection requiring systemic anti-infective treatment within 14 days prior to the administration of the investigational product. 19. Have received any major surgery (defined as surgeries requiring at least 3 weeks of recovery to be able to receive treatment in this study) within 28 days prior to the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-tumor efficacy of HLX10 in combination with chemotherapy and concurrent radiotherapy in subjects with LS-SCLC.;Secondary Objective: To evaluate the safety of HLX10 in combination with chemotherapy and concurrent radiotherapy in subjects with LS-SCLC. To evaluate the pharmacokinetics (PK), immunogenicity, and biomarkers;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: Once every 12 weeks ± 7 days after the last dose of HLX10/placebo, until the withdrawal of informed consent, death, loss to follow-up, study discontinuation decided by the sponsor, or the end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Progression-free survival (PFS, assessed by the investigator as per RECIST v1.1) - Objective response rate (ORR) (assessed by the investigator as per RECIST 1.1) - Duration of remission (DOR) (assessed by the investigator as per RECIST 1.1) - Adverse events (AE) (including serious adverse events (SAE)), laboratory tests (hematology, blood chemistry, coagulation function, urinalysis, thyroid function, and cardiac function), 12-lead electrocardiogram (12-lead ECG), vital signs, and physical examination - Quality of life assessment - Serum HLX10 concentration - HLX10 anti-drug antibody (ADA/NAb) - Relationship between PD-L1 expression in tumor tissuesand efficacy;Timepoint(s) of evaluation of this end point: PFS-As assessed by the investigator as per RECIST v1.1, assessed when screening(within 4 weeks pre-dose), every 6 weeks (± 7 days) during the first 48 weeks after the start of study treatment, and every 9 weeks (± 7 days) after week 48. ORR-As assessed by the investigator as per RECIST v1.1. DOR-As assessed by the investigator as per RECIST v1.1. AEs-As assessed by the investigator during visit or informed by subject. Quality of life assessment-Once during screening period, once prior before the administration every 2 cycles until EOT visit. PK and ADA/NAb-within 7 days pre-dose in cycle1, within 3 days pre-dose in cycle2,4,6,8 and every 4 cycles thereafter, within 2 hours after the end of dosing in cycles 1 and 8 of treatment period(for PK only), at EOT visit and safety follow-up. | — |
Countries
Australia, Austria, China, Czechia, Czech Republic, Germany, Greece, Hong Kong, Hungary, Latvia, Netherlands, Poland, Spain, United States
Contacts
Public ContactSha Deng
Shanghai Henlius Biotech, Inc.
Outcome results
None listed