early-stage non-small cell lung cancer
Conditions
Interventions
Single-arm study:Stereotactic ablative radiotherapy combined with immunotherapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Histologically confirmed NSCLC, clinically diagnosed as early-stage. According to the AJCC 9th edition staging system, early-stage is defined as stage IA-IB (tumor size 4cm and =1.5×10?/L; Absolute Lymphocyte Count (ALC) >=0.5×10?/L; Platelet Count (PLT) >=100×10?/L; Hemoglobin (Hb) >=9.0 g/dL. b) Liver function: Serum Total Bilirubin (TBIL) =50 mL/min; Urine dipstick test shows proteinuria =50% within 28 days prior to the first dose; 9. Pulmonary function tests performed within 28 days prior to the first study treatment, with Predicted Postoperative Forced Expiratory Volume in 1 second (PPO-FEV1) and Predicted Postoperative Diffusing Capacity for Carbon Monoxide (PPO-DLCO) >=40% of predicted values. If clinically indicated, further assessment of pulmonary function via quantitative ventilation/perfusion scan or cardiopulmonary exercise testing may be performed, with Maximum Oxygen Consumption (VO2max) >10 mL/kg/min. Tests may be repeated during screening if clinically indicated.
Exclusion criteria
Exclusion criteria: 1. Clinically assessed by two or more radiation oncology experts at the level of associate chief physician or above as not meeting the criteria for SABR; 2. History of other malignancies within the past 5 years prior to screening (except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, ductal carcinoma in situ after radical treatment, and papillary thyroid carcinoma), or presence of synchronous multiple primary early-stage NSCLC; 3. Any additional planned prior local or systemic therapy; 4. Presence of EGFR-sensitive mutation positivity or ALK fusion; 5. Pulmonary lesion identified as a pure ground-glass nodule; 6. History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; 7. Active, known, or suspected autoimmune disease; 8. Known history of primary immunodeficiency; 9. Systemic immunosuppressive therapy (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-tumor necrosis factor agents) within 2 weeks prior to the first dose, or subjects expected to require systemic immunosuppressive medication during the study treatment period. Subjects who have received short-term, low-dose (= Grade 2 peripheral neuropathy; 14. Untreated acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] at screening with HBV-DNA >=500 IU/mL or above the upper limit of normal at the local laboratory) or hepatitis C (defined as positive hepatitis C antibody [HCV-Ab] at screening with positive HCV-RNA). Subjects undergoing antiviral therapy may be enrolled based on the physician's judgment of the individual case, with monitoring of viral load; 15. Uncontrolled concurrent illnesses, including but not limited to: a) HIV infection (positive HIV antibody). b) Severe infections in active phase or poorly controlled clinically. c) Evidence of severe or uncontrolled systemic diseases (e.g., severe psychiatric, neurological, epileptic, or dementia disorders; uncompensated or unstable respiratory, cardiovascular, hepatic, or renal diseases; uncontrolled hypertension [defined as >= Grade 2 hypertension per CTCAE v5.0 despite medication]). d) Active bleeding or newly diagnosed thrombotic disease requiring therapeutic anticoagulation or subjects with bleeding tendency. e) Active malignancy within the past 5 years, except for locally treatable cancers that have been clearly cured.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Recurrence patterns;Overall Survival;Quality of Life;Incidence of adverse reactions.; | — |
Countries
China
Contacts
Public ContactXiaojiang Sun
Zhejiang Cancer Hospital
Outcome results
None listed