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.
The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.
Pathologically confirmed LS-SCLC
Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1
ECOG performance status of 0 or 1
Known hypersensitivity to QL1706 or any of its excipients
Histologically confirmed non-small cell lung cancer (NSCLC) or mixed tumor containing an NSCLC component.
History of another primary malignancy or previous allogeneic organ transplantation.
Surgery (other than diagnostic biopsy) within 4 weeks before first dose of study drug.
Single group
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
DrugInduction: 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
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
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
Objective Response Rate (ORR)
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)
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).
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)
Click on the lead sponsor to view all of their trials.
