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New treatment option for Limited-stage Small Cell Lung Cancer (LS-SCLC)
Official title A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
ClinicalTrials.gov ID: NCT07091305
What this study is testing
What is QL1706 (bispecific antibody targeting PD-1 and CLTA-4)?
QL1706 (bispecific antibody targeting PD-1 and CLTA-4) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for limited-stage small cell lung cancer (ls-sclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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...
See the full eligibility 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
- 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 ×...
- 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 people...
- No prior systemic anti-tumor therapy before enrollment.
- Estimated life expectancy ≥ 12 weeks.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.