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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: placebo for QL1604; Drug: QL1604; Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)

• Study Type: Interventional
• Enrollment (Estimated): 636
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zekai Yu, bachelor's degree; Phone Number: 18611428367; Email: zekai.yu@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1706 group; Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks	Drug: Iparomlimab and Tuvonralimab (QL1706); 5mg/kg , every 3 weeks; Drug: placebo for QL1604; every 3 weeks
Active Comparator: QL1604 group; QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks	Drug: QL1604; 200mg, every 3 weeks; Drug: placebo for Iparomlimab and Tuvonralimab (QL1706); every 3 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: QL1706-310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No