Clinical trial · Interventional
a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.
A Randomized, Double-blind Phase III Clinical Study of QL1706 Versus QL1604 as Consolidation Treatment in Patients With Limited-stage Small Cell Lung Cancer Who Have Not Experienced Disease Progression After Concurrent or Sequential Chemoradiotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706) | Drug | — | UNRESOLVED |
| placebo for Iparomlimab and Tuvonralimab (QL1706) | Drug | — | UNRESOLVED |
| placebo for QL1604 | Drug | — | UNRESOLVED |
| QL1604 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QL1706 group
- description
- Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks
- interventionNames
- Drug: Iparomlimab and Tuvonralimab (QL1706)
- Drug: placebo for QL1604
- type
- ACTIVE_COMPARATOR
- label
- QL1604 group
- description
- QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks
- interventionNames
- Drug: QL1604
- Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)
Primary outcomes (2)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 \[I-III stage SCLC (any T, any N, M0)\], according to the American Joint Committee on Cancer (AJCC, 8th edition) staging manual. * Received 4 cycles of chemotherapy concurrent or sequential with radiotherapy. Chemotherapy must contain platinum and etoposide. Radiotherapy must be either total 60-70 Gy over 6 weeks for the QD regimen or total 45 Gy over 3 weeks for BID schedules. * Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry. Exclusion Criteria: * Mixed SCLC and non-small cell lung cancer (NSCLC). * Extensive-stage SCLC. * Active or prior documented autoimmune or inflammatory disorders. * Received other chemotherapy regimens besides etoposide and platinum-based therapy. * Active or prior documented autoimmune or inflammatory disorders. * Presence of interstitial lung disease or active non-infectious pneumonia (excluding grade 1 radiation pneumonitis not treated with corticosteroids).
References
Publications (0)
Data not yet available