NSCLC
Conditions
Interventions
Gold Standard:Histopathological TRG grading (residual tumor >=70% indicating treatment inefficacy) results
Index test:PTC model drug sensitivity testing results
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18–75 years, regardless of gender; 2.Diagnosis: Histologically confirmed locally advanced non-small cell lung cancer (NSCLC) (clinical stage: T1-4N1M0, T1-3N2aM0, or T1N2bM0 per the 8th edition UICC-TNM staging system); 3.Clinical Indication: Assessed as eligible for preoperative neoadjuvant therapy (chemotherapy or chemotherapy combined with immunotherapy); 4.Prior Therapy: No prior antitumor treatment for lung cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormonal therapy, or immunotherapy; 5.Performance Status: ECOG PS score of 0–2; 6.Organ Function: No surgical contraindications based on comprehensive organ function evaluations; 7.Laboratory Requirements (confirmed within 14 days prior to screening without blood transfusion or use of hematopoietic growth factors, e.g., G-CSF, GM-CSF, EPO, TPO): Hemoglobin >=90 g/L; White blood cell count >= institutional lower limit of normal (LLN); Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count >=100×10^9/L; Total bilirubin =50 mL/min (calculated via Cockcroft-Gault formula); 8.Informed Consent: Voluntarily sign written informed consent after understanding the study protocol.
Exclusion criteria
Exclusion criteria: 1.History of Other Malignancies: Diagnosis of any malignancy other than lung cancer within 5 years prior to enrollment, except for cured localized tumors (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, or prostate carcinoma in situ). Prostate cancer patients who received hormone therapy and achieved >=5-year disease-free survival (DFS) are eligible; 2.Severe Cardiovascular/Cerebrovascular Diseases:NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, poorly controlled rrhythmias, or cerebrovascular accident within 12 months prior to enrollment. Poorly controlled hypertension (systolic blood pressure >=150 mmHg and/or diastolic blood pressure >=100 mmHg; average of >=2 measurements). Prior hypertensive crisis or hypertensive encephalopathy; 3.Interstitial Lung Disease: History of interstitial lung disease or pneumonia requiring steroid therapy at enrollment; 4.Bloodborne Infectious Diseases: Including but not limited to hepatitis B virus carriers, hepatitis C, syphilis, or HIV infection; 5.Severe Hypersensitivity: Prior severe allergic reactions to chemotherapeutic agents (e.g., paclitaxel, carboplatin) or any monoclonal antibody; 6.Active Autoimmune Disease: Active autoimmune disease requiring systemic treatment (e.g., immunomodulatory agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Exclusions do not apply to replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal/pituitary insufficiency); 7.Pregnancy: Female patients who are pregnant; 8.Investigator Discretion: Patients deemed ineligible for participation based on comprehensive clinical assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Overall concordance rate;Cohen’s Kappa coefficient (?) for inter-rater agreement; | — |
Countries
China
Contacts
Public ContactShaohua Ma
Beijing Cancer Hospital
Outcome results
None listed