Clinical trial · Interventional
Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer
A Single-center, Single-arm Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer
NCT07379398CI-TRIAL-00109710not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Major objectives to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with SBRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lparomlimab and Tuvonralimab Injection in Combination with SBRT
- description
- lparomlimab and Tuvonralimab Injection in Combination with SBRT
- interventionNames
- Drug: lparomlimab and Tuvonralimab Injection in Combination with SBRT
Primary outcomes (1)
- measure
- 1-year EFS
- timeFrame
- up to 12 month
Secondary outcomes (3)
- measure
- Objective response rate
- timeFrame
- up to 12 month
- description
- the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Understand and voluntarily sign the informed consent form for this study; * Age ≥ 18 years; * ECOG performance status of 0-1; * Histologically confirmed non-small cell lung cancer, meeting AJCC 8th edition Stage IA-IB (tumor size ≤ 4cm, N0M0), Stage IIA (≤5cm, N0M0), or Stage IIB (\>5cm and ≤7cm, N0M0); * At least one repeatable measurable lesion at baseline (according to RECIST 1.1 criteria); * Function of vital organs within 7 days prior to initial treatment meets the following requirements (use of any blood components or colony-stimulating factors within 14 days prior to enrollment is not allowed): Hemoglobin (Hb) ≥ 90 g/L; White Blood Cell (WBC) count ≥ 3.5 × 10\^9/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L; Platelets (PLT) ≥ 80 × 10\^9/L; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN); if liver metastases are present, AST and ALT ≤ 5 × ULN; Total Bilirubin (TBIL) ≤ 1.5 × ULN; Blood Urea Nitrogen (BUN) and Creatinine (Cr) ≤ 1.5 × ULN (and Creatinine Clearance (CCr) ≥ 50 mL/min); Left Ventricular Ejection Fraction (LVEF) ≥ 50%; QT interval corrected by Fridericia's formula (QTcF) \< 470 milliseconds; * Eligible patients of childbearing potential must agree to use a reliable method of contraception together with their partner during the trial period and for at least 180 days after the last dose of the study drug. Exclusion Criteria: * Inability to comply with the research protocol or study procedures. * Previous receipt of any treatment, including chemotherapy or radiotherapy, for the currently diagnosed lung cancer. * Patients with positive driver gene mutations such as EGFR, ALK, or ROS1. * History of allergy or hypersensitivity to the investigational drug(s) or any of their excipients, or a history of atopy. * Presence of active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs indicating severe pulmonary impairment during the screening period. * Concurrent severe cardiovascular or cerebrovascular diseases. * Receipt of broad-spectrum antibiotic therapy via any route within 30 days prior to the first dose. * Positive anti-HIV test; positive Hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal (ULN); active Hepatitis C virus (HCV) infection. * Evident bleeding tendency or other significant evidence of coagulation disorders. * Current interstitial pneumonia or interstitial lung disease, or a prior history of interstitial pneumonia or interstitial lung disease requiring corticosteroid treatment; or other conditions such as pulmonary fibrosis or organizing pneumonia that may interfere with the assessment and management of immune-related pulmonary toxicity. * Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage (except for cases with only minimal ascites visible on imaging without clinical symptoms), or uncontrolled or moderate-to-large pleural effusion or pericardial effusion. * Ongoing systemic corticosteroid therapy or other immunosuppressive agents within 14 days prior to the first dose, or use of immunostimulants (including but not limited to interferon or interleukin-2) within 4 weeks prior. * Diagnosis of other malignancies within 5 years prior to enrollment, except for radically resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix. * Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment. * Patients deemed by the investigator to be unsuitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.