Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer

Official title

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

Overview

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.

Detailed description

This single-arm, single-center clinical study aims 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. This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Interventions

• Drug lparomlimab and Tuvonralimab Injection in Combination with SBRT
  lparomlimab and Tuvonralimab Injection: 5 mg/kg, administered every 3 weeks (q3w). The first dose should be given within one week after the initial SBRT fraction. The treatment duration is one year. SBRT: 50 Gy in 4 fractions or 70 Gy in 10 fractions, to be completed within 1-2 weeks.

Primary outcome measures

• 1-year EFS [Time frame: up to 12 month]

Secondary outcome measures (3)

• Objective response rate [Time frame: up to 12 month]
• Overall survival [Time frame: up to 36 month]
• Adverse Events [Time frame: up to 36 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07379398 · E20251143A

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗