Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
experiment group:Induction Chemo-Immunotherapy followed by Thoracic Radiotherapy and Consolidation Immunotherapy
Sponsors
Meishan City Peoples Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically or pathologically confirmed NSCLC diagnosed as unresectable Stage III disease according to The IASLC Staging Manual in Thoracic Oncology, 8th Edition. 2.ECOG performance status 0-2; 3.Age >=18 years; 4.No prior antitumor therapy for Stage III NSCLC; 5.>=6-month treatment-free interval after neoadjuvant/adjuvant chemotherapy if previously administered. 6.No prior thoracic radiotherapy; 7.Adequate organ function within 14 days prior to enrollment: Hematology: WBC >=3.5×10^9/L ANC >=1.5×10^9/L Platelets >=75×10^9/L Hemoglobin >=10 g/dL Cardiac: No acute cardiac failure Hepatic: Total bilirubin =3 g/dL Renal (either criterion): Serum creatinine =60 mL/min; 8.Voluntary written informed consent with protocol compliance; 9.Life expectancy >6 months; 10.>=1 radiologically measurable lesion per RECIST v1.1;
Exclusion criteria
Exclusion criteria: 1.Active autoimmune disease or history of autoimmune disorders with recurrence potential*; *Exceptions: Well-controlled type 1 diabetes Hypothyroidism requiring hormone replacement only Skin disorders not necessitating systemic therapy (e.g., vitiligo, psoriasis, alopecia) Conditions without recurrence risk absent external triggers*; 2.History of interstitial lung disease (ILD), non-infectious pneumonitis, or pulmonary fibrosis; 3.Active infections requiring systemic antimicrobial therapy (antibacterial/antifungal/antiviral), including tuberculosis; 4.Known sensitizing EGFR mutations or ALK/ROS1 alterations; 5.Prior invasive malignancy; 6.Uncontrolled cardiac conditions: Uncontrolled hypertension (SBP >160 mmHg despite medication) Unstable angina Myocardial infarction within 6 months Uncontrolled Congestive Heart Failure Reduced ejection fraction cardiomyopathy; 7.Pregnancy, lactation, or refusal of medically acceptable contraception; 8.Prior anti-PD-1/PD-L1 immune checkpoint inhibitors or pathway-targeted therapies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-Month Progression-Free Survival Rate;Incidence of Grade =3 Pneumonitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;duration of response;safety;objective response rate;overall survival;progress free survival; | — |
Countries
China
Contacts
Public ContactZou Yao
Meishan City Peoples Hospital
Outcome results
None listed