NSCLC
Conditions
Keywords
lparomlimab and Tuvonralimab Injection, SBRT, early-stage
Brief 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.
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
DRUGlparomlimab 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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year EFS | up to 12 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | up to 12 month | 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. |
| Overall survival | up to 36 month | OS was defined as the time from the first dose of study drug to death due to any cause. |
| Adverse Events | up to 36 month | An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment. |
Countries
China
Contacts
CONTACTNingbo Liu
PRINCIPAL_INVESTIGATORZhiyong Yuan
Tianjin Medical University Cancer Institute and Hospital
PRINCIPAL_INVESTIGATORNingbo Liu
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed