This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
Age ≥18 years.
Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
No prior systemic treatment for ES-SCLC.
At least one extracranial measurable lesion according to RECIST v1.1.
Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
Major surgery within 4 weeks prior to the study treatment.
Parallel
QLC5508
DrugQLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107
DrugQL2107 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for QL2107 will be 2 years.
Tislelizumab
DrugTislelizumab will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for Tislelizumab will be 2 years.
Carboplatin
DrugCarboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin
DrugCisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.
Etoposide
DrugEtoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.
Overall survival (OS)
OS is defined as the duration from the date of randomization to the date of death due to any cause.
Progression-free survival (PFS)
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
Objective response rate (ORR)
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
Duration of response (DOR)
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
Disease control rate (DCR)
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
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