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NCT Number: NCT06789796

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

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Iparomlimab and Tuvonralimab (QL1706)

Drug

5mg/kg , every 3 weeks

placebo for QL1604

Drug

every 3 weeks

QL1604

Drug

200mg, every 3 weeks

placebo for Iparomlimab and Tuvonralimab (QL1706)

Drug

every 3 weeks

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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

  2. Overall survival (OS)

    Time frame: 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 outcomes

  1. objective response rate (ORR)

    Time frame: 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

  2. disease control rate (DCR)

    Time frame: 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

  3. duration of response (DoR)

    Time frame: 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

  4. PFS

    Time frame: 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

  5. 1-year OS rate

    Time frame: 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

  6. 2-year OS rate

    Time frame: 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

  7. adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zekai Yu, bachelor's degree

CONTACT

[email protected]

18611428367

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jan 23, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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