Trials / Active Not Recruiting
Active Not RecruitingNCT07091305
A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy：A Phase II Trial
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Shanghai Chest Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Limited-stage Small Cell Lung Cancer (LS-SCLC)
- Chemoradiotherapy
- Induction Therapy
- Consolidation Immunotherapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL1706 (bispecific antibody targeting PD-1 and CLTA-4) | 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 |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2027-08-01
- Completion
- 2028-08-01
- First posted
- 2025-07-29
- Last updated
- 2025-07-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07091305. Inclusion in this directory is not an endorsement.