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a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy. | Clinical Trials | Clareo Health

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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.

NCT06789796•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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).

Key Dates

Start Date

February 1, 2025

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2030

Last Updated

February 11, 2025

Enrollment

636

ESTIMATED participants

Conditions

Small-cell Lung Cancer

Interventions

Iparomlimab and Tuvonralimab (QL1706)

DRUG

placebo for QL1604

DRUG

QL1604

DRUG

placebo for Iparomlimab and Tuvonralimab (QL1706)

DRUG

Contacts

Zekai Yu, bachelor's degree

CONTACT

18611428367 zekai.yu@qilu-pharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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