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Not yet recruiting NCT06789796

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

Phase III Interventional Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iparomlimab and Tuvonralimab (QL1706), placebo for QL1604, QL1604, placebo for Iparomlimab and Tuvonralimab (QL1706).
Who it may be relevant to
Registry conditions: Small-cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Drug Iparomlimab and Tuvonralimab (QL1706)
    5mg/kg , every 3 weeks
  • Drug placebo for QL1604
    every 3 weeks
  • Drug QL1604
    200mg, every 3 weeks
  • Drug placebo for Iparomlimab and Tuvonralimab (QL1706)
    every 3 weeks

Primary outcome measures

  • Progression-free survival (PFS) [Time frame: up to 2 years]
  • Overall survival (OS) [Time frame: up to 5 years]
Secondary outcome measures (7)
  • objective response rate (ORR) [Time frame: up to 2 years]
  • disease control rate (DCR) [Time frame: up to 2 years]
  • duration of response (DoR) [Time frame: up to 2 years]
  • PFS [Time frame: up to 2 years]
  • 1-year OS rate [Time frame: up to 1 year]
  • 2-year OS rate [Time frame: up to 2 years]
  • adverse events [Time frame: up to 2 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06789796 · QL1706-310

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗