a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.

Phase 3

Not yet recruiting

• Conditions: Small-cell Lung Cancer
• Interventions: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: QL1604; Drug: placebo for QL1604; Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)

• Registration Number: NCT06789796
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Study Start: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2028-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 636

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL1706 group	Iparomlimab and Tuvonralimab (QL1706)	Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks
QL1706 group	placebo for QL1604	Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks
QL1604 group	QL1604	QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks
QL1604 group	placebo for Iparomlimab and Tuvonralimab (QL1706)	QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 2 years	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
Overall survival (OS)	up to 5 years	To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by OS

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	up to 2 years	To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by ORR
disease control rate (DCR)	up to 2 years	To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DCR
duration of response (DoR)	up to 2 years	To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DoR
PFS	up to 2 years	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
1-year OS rate	up to 1 year	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
2-year OS rate	up to 2 years	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
adverse events	up to 2 years	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.