A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy

NCT07091305 | Active Not Recruiting Phase 2

• 1 other identifier: IS25129
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis. QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.

Conditions

Limited-stage Small Cell Lung Cancer (LS-SCLC); Chemoradiotherapy; Induction Therapy; Consolidation Immunotherapy

Keywords

Limited-stage small cell lung cancer; QL1706; chemoradiotherapy; induction therapy; consolidation immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To evaluate the efficacy of QL1706 combined with chemotherapy as induction therapy followed by chemoradiotherapy (CRT) for patients with LS-SCLC as measured by investigator-assessed PFS

  up to 12 months after the last participant entry

Secondary Outcomes (7)

• Overall Survival (OS)

  up to 12 months after the last participant entry

• Objective Response Rate (ORR)

  through study completion, an average of 12 months after last patient entry

• Duration of Response (DoR)

  time from the first tumor assessment showing response to disease progression or death (whichever occurs first),assessed up to 24 months

• Disease Control Rate (DCR)

  through study completion, an average of 12 months

• Quality-of-life(QoL)

  Through study completion, an average of 12 months after last participant entry

Study Arms (1)

Experimental arm

EXPERIMENTAL

Induction: QL1706 combined with Etoposide and platinum, intravenous infusion (IV), every 3 weeks. Chemoradiotherapy, followed by QL1706 consolidation, intravenous infusion (IV), every 3 weeks.

Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

Interventions

QL1706 (bispecific antibody targeting PD-1 and CLTA-4) DRUG

Induction: QL1706 5 mg/kg IV on Day 1, Etoposide: 100 mg/m² IV on Days 1-3, Cisplatin or Carboplatin: Cisplatin 75 mg/m² IV on Day 1 or Cisplatin 25 mg/m² IV on Days 1-3, Or Carboplatin AUC = 5 IV on Day 1, Q3W, for a total of 2 cycles. Chemoradiotherapy：Thoracic Radiotherapy（60 Gy in 30 fractions, once daily (2 Gy/fraction), or 45 Gy in 30 fractions, twice daily (1.5 Gy/fraction)），Etoposide 100 mg/m² IV on Days 1-3, Cisplatin either 75 mg/m² IV on Day 1, or 25 mg/m² IV on Days 1-3, Or Carboplatin AUC=5 IV on Day 1 PCI: Patients achieving or approaching complete response, per investigator assessment, 25Gy in 10 fractions. Consolidation: QL1706 5 mg/kg IV on Day 1, Q3W

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1
• ECOG performance status of 0 or 1
• Forced expiratory volume in one second (FEV₁) \> 1.0 L
• No clinically significant interstitial lung disease on baseline CT or PET/CT.
• Adequate organ and bone-marrow function (all tests performed within 7 days prior to first dose; no transfusions, growth factors, albumin, or other corrective therapies within 14 days):Hemoglobin ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 90 × 10⁹/L,Serum creatinine ≤ 1.5 × ULN, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Albumin (ALB) ≥ 25 g/L,INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN (subjects on prophylactic anticoagulation must have values within a safe therapeutic range, per investigator)
• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use reliable contraception from screening until 3 months after the last dose; male subjects must agree to use effective contraception or have undergone surgical sterilization for the same period.
• No prior systemic anti-tumor therapy before enrollment.
• Estimated life expectancy ≥ 12 weeks.

You may not qualify if:

• Known hypersensitivity to QL1706 or any of its excipients
• Histologically confirmed non-small cell lung cancer (NSCLC) or mixed tumor containing an NSCLC component.
• History of another primary malignancy or previous allogeneic organ transplantation.
• Surgery (other than diagnostic biopsy) within 4 weeks before first dose of study drug.
• Active substance abuse (e.g., illicit drug use), chronic alcoholism, AIDS, or known HIV infection.
• Active autoimmune disease, or history of autoimmune disease likely to recur. Systemic corticosteroid therapy equivalent to \>10 mg/day prednisone (or other immunosuppressive therapies) within 14 days before first dose.
• Prior therapy with any antibody or agent targeting T-cell co-regulatory proteins (e.g., PD-1, PD-L1, CTLA-4, TIM-3, LAG-3).
• Interstitial lung disease (ILD), or history of ILD requiring steroid therapy. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonia on screening chest CT.
• Live vaccine administration within 28 days prior to first study drug dose. Any condition or comorbidity contraindicating chemo- or radiotherapy (e.g., active infection, myocardial infarction within 6 months, symptomatic heart disease including unstable angina, congestive heart failure, uncontrolled arrhythmia, ongoing immunosuppressive therapy).
• Pregnant or breastfeeding women; women of childbearing potential or men unwilling to use adequate contraception.
• Known hereditary bleeding diathesis or coagulation disorder.
• Prior malignancy, except adequately treated non-melanoma skin cancer, or in situ carcinoma (e.g., breast, oral, cervical) with expected survival \>3 years.
• Any other medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, could interfere with trial participation or interpretation of results.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)