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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
556
QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107 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 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.
Overall survival (OS)
OS is defined as the duration from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 36 months
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.
Time frame: Up to approximately 36 months
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.
Time frame: Up to approximately 36 months
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.
Time frame: Up to approximately 36 months
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.
Time frame: Up to approximately 36 months
6-month PFS rate
The 6-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 6 months from the date of randomization.
Time frame: Up to approximately 36 months
12-month PFS rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.
Etoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.
The 12-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 12 months from the date of randomization.
Time frame: Up to approximately 36 months
12-month OS rate
The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization.
Time frame: Up to approximately 36 months
24-month OS rate
The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization.
Time frame: Up to approximately 36 months
Treatment Emergent Adverse Event (TEAE)
TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Time frame: Up to approximately 36 months