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The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis.
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 |
|---|---|---|---|
| Experimental arm | Experimental | Induction: QL1706 combined with Etoposide and platinum, intravenous infusion (IV), every 3 weeks. Chemoradiotherapy, followed by QL1706 consolidation, intravenous infusion (IV), every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 (bispecific antibody targeting PD-1 and CLTA-4) | Drug | Induction: QL1706 5 mg/kg IV on Day 1, Etoposide: 100 mg/m² IV on Days 1-3, Cisplatin or Carboplatin: Cisplatin 75 mg/m² IV on Day 1 or Cisplatin 25 mg/m² IV on Days 1-3, Or Carboplatin AUC = 5 IV on Day 1, Q3W, for a total of 2 cycles. Chemoradiotherapy:Thoracic Radiotherapy(60 Gy in 30 fractions, once daily (2 Gy/fraction), or 45 Gy in 30 fractions, twice daily (1.5 Gy/fraction)),Etoposide 100 mg/m² IV on Days 1-3, Cisplatin either 75 mg/m² IV on Day 1, or 25 mg/m² IV on Days 1-3, Or Carboplatin AUC=5 IV on Day 1 PCI: Patients achieving or approaching complete response, per investigator assessment, 25Gy in 10 fractions. Consolidation: QL1706 5 mg/kg IV on Day 1, Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | To evaluate the efficacy of QL1706 combined with chemotherapy as induction therapy followed by chemoradiotherapy (CRT) for patients with LS-SCLC as measured by investigator-assessed PFS | up to 12 months after the last participant entry |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | To evaluate the efficacy of QL1706 combined with chemotherapy as induction therapy followed by chemoradiotherapy (CRT) for patients with LS-SCLC as measured by investigator-assessed OS | up to 12 months after the last participant entry |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuwei Cai | Contact | 02122200000 | birdhome2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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|
Assessed according to RECIST V1.1.The Objective Response Rate (ORR) is defined as the best ORR during the study period, including cases of Complete Response (CR) and Partial Response (PR) |
| through study completion, an average of 12 months after last patient entry |
| Duration of Response (DoR) | For patients who achieve Complete Response (CR) or Partial Response (PR), the time from the first tumor assessment showing response to disease progression or death (whichever occurs first). | time from the first tumor assessment showing response to disease progression or death (whichever occurs first),assessed up to 24 months |
| Disease Control Rate (DCR) | DCR refers to the percentage of cases with the best efficacy evaluation of "Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) | through study completion, an average of 12 months |
| Quality-of-life(QoL) | QoL scores will be transformed to a scale of 0-100 according to the EORTC QLQ scoring manual. Mean scores will be compared at each assessment timepoint, and a difference of 10 points is considered clinically relevant. | Through study completion, an average of 12 months after last participant entry |
| Correlation between outcomes of study treatment and biomarkers in tissue, blood | A detailed plan for analyses will be defined when sufficient material for translational research has been collected. | Through study completion, an average of 2 years after last patient entry |
| Adverse events(AE) | Number of participant with treatment-related adverse events assessed based on CTCAE v5.0 | through study completion, an average of 12 months |
| 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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