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The study is being conducted to evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy.
QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 group | Experimental | Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks |
|
| QL1604 group | Active Comparator | QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706) | Drug | 5mg/kg , every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS | up to 2 years |
| Overall survival (OS) | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by OS | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by ORR | up to 2 years |
| disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zekai Yu, bachelor's degree | Contact | 18611428367 | zekai.yu@qilu-pharma.com |
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| placebo for QL1604 |
| Drug |
every 3 weeks |
|
| QL1604 | Drug | 200mg, every 3 weeks |
|
| placebo for Iparomlimab and Tuvonralimab (QL1706) | Drug | every 3 weeks |
|
To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DCR
| up to 2 years |
| duration of response (DoR) | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DoR | up to 2 years |
| PFS | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by Investigator-assessed PFS | up to 2 years |
| 1-year OS rate | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by 1-year OS rate | up to 1 year |
| 2-year OS rate | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by 2-year OS rate | up to 2 years |
| adverse events | To compare and evaluate the safety of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters. | up to 2 years |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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