Extensive-stage Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGQLC5508
QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
DRUGQL2107
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.
DRUGTislelizumab
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.
DRUGCarboplatin
Carboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.
DRUGCisplatin
Cisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.
DRUGEtoposide
Etoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. 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. 3. No prior systemic treatment for ES-SCLC. 4. At least one extracranial measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment. 6. Life expectancy ≥12 weeks. 7. Has adequate organ function. 8. Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy. 9. Voluntarily sign the written informed consent form and comply with the protocol requirements.
Exclusion criteria
1. Has received or undergoing any of the following treatment: Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors. 2. 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. 3. Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression. 4. 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. 5. Major surgery within 4 weeks prior to the study treatment. 6. Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy. 7. Previous or concurrent primary malignancies. 8. History of severe heart disease or cerebrovascular disease. 9. History of Severe or uncontrolled hypertension or diabetes mellitus. 10. Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening. 11. Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity. 12. Known history of pre-existing or newly diagnosed autoimmune disease. 13. History of severe neuropathy or mental disorders. 14. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs. 15. Unlikely to comply with study procedures and requirements in the opinion of the investigator. 16. Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 36 months | OS is defined as the duration from the date of randomization to the date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month OS rate | Up to approximately 36 months | The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization. |
| 24-month OS rate | Up to approximately 36 months | The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization. |
| Treatment Emergent Adverse Event (TEAE) | Up to approximately 36 months | 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. |
| Progression-free survival (PFS) | Up to approximately 36 months | 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) | Up to approximately 36 months | 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) | Up to approximately 36 months | 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) | Up to approximately 36 months | DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria. |
| 12-month PFS rate | Up to approximately 36 months | 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. |
| 6-month PFS rate | Up to approximately 36 months | 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. |
Contacts
CONTACTHaiying Yu, Bachelor
Outcome results
None listed