A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation … (NCT07091305) | Clinical Trial Compass
RecruitingPhase 2
A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
China28 participantsStarted 2025-10-23
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing QL1706, which is a newer immunotherapy drug, combined with chemotherapy before and after chemoradiotherapy — since this is only a Phase 2 study, how much do we actually know about the safety and effectiveness of this specific combination in limited-stage small cell lung cancer so far?
2The trial involves induction chemotherapy, then chemoradiotherapy, and then ongoing immunotherapy consolidation — given how intensive that sequence is, is my current health status and fitness level realistically compatible with completing the full treatment plan?
3The main thing being measured in this trial is progression-free survival, meaning how long before the cancer grows or spreads — is that a meaningful goal for my specific situation, or should I be asking about overall survival data as well when comparing this to standard treatment options?
4Since limited-stage small cell lung cancer already has established standard-of-care chemoradiotherapy approaches, would you recommend I try the proven standard treatment first before considering an experimental trial like this one?
5QL1706 is described as a dual checkpoint inhibitor targeting both PD-1 and CTLA-4 pathways — does my particular case or any biomarker results suggest I might be more or less likely to respond to that type of immunotherapy approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: up to 12 months after the last participant entry
. 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.
Exclusion criteria
. 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.