Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small … (NCT07379398) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer
China28 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
1-year EFS
Timeframe: up to 12 month
Trial details
NCT IDNCT07379398
SponsorTianjin Medical University Cancer Institute and Hospital