non-small cell lung cancer
Conditions
Interventions
Experimental Group:Neoadjuvant treatment with platinum-based doublet chemotherapy combined with tislelizumab and voriconazole
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study and signs the informed consent form; 2. Male or female patients aged between 18 and 75 years old; 3. Histologically confirmed non-small cell lung cancer (NSCLC), with resectable stage II–III disease (AJCC 9th edition); 4. No prior systemic antitumor treatment for this lung cancer (including chemotherapy, immunotherapy, or targeted therapy); 5. Meets the indications for NSCLC immunotherapy, without known EGFR, ALK, ROS1, or other driver gene mutations; 6. Detection of Aspergillus in the subject's bronchoalveolar lavage fluid (BALF) by fluorescence PCR method; 7. At least one measurable lesion according to RECIST 1.1 criteria; 8. ECOG performance status score of 0–1; 9. Adequate major organ function, meeting the following criteria: (1) Hematologic parameters must meet the standards below (no blood transfusion or blood products within 14 days prior, no use of G-CSF or other hematopoietic growth factors for correction): (2) Hemoglobin (HB) >= 90 g/L; Note: Patients must not have received blood transfusion or growth factor support within = 1.5 × 10^9/L (1500/mm^3); (4) Platelet count (PLT) >= 100 × 10^9/L; (5) International normalized ratio (INR) or prothrombin time (PT) 45 mL/min (Cockcroft-Gault formula); 10. Female patients of childbearing potential must voluntarily adopt highly effective contraceptive measures from the study period through >= 120 days after the last dose (whichever is later), and have a negative urine or serum pregnancy test result within = 120 days after the last dose (whichever is later). 11. Expected survival time >= 3 months.
Exclusion criteria
Exclusion criteria: 1. Mixed-type lung cancer with small cell carcinoma, neuroendocrine carcinoma, or sarcomatoid components is not eligible for enrollment; 2. Received any of the following treatments: (1) Prior treatment with any immune checkpoint inhibitor (anti-PD-1/PD-L1, etc.); (2) Major surgery within 4 weeks prior to the first dose of study drug (e.g., craniotomy; thoracotomy or laparotomy, etc.), with major surgery defined as Grade 3 and Grade 4 surgeries specified in the "Administrative Measures for Clinical Application of Medical Technologies" implemented on November 1, 2018; (3) Radiation therapy to more than 30% of the bone marrow, or extensive-field radiotherapy within 4 weeks prior to the first dose of study drug; (4) Use of, or requirement for, strong CYP3A4 inhibitors, strong inducers, or drugs with narrow therapeutic windows that are sensitive CYP3A4 substrates within 7 days prior to the first dose of study drug (as azole antifungals are CYP3A4 inhibitors/substrates, posing interaction risk). 3. Active, known, or suspected autoimmune disease (well-controlled Type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment such as vitiligo or psoriasis are permitted); 4. Medical history or comorbidities: (1) Active fungal (other than Aspergillus), bacterial, or viral infections requiring systemic treatment (e.g., active pulmonary tuberculosis); (2) Patient currently participating in another clinical study, or with less than 4 weeks since completion of the previous clinical study treatment; (3) Other active malignancies requiring concurrent treatment; (4) History of interstitial lung disease, drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease; (5) Renal insufficiency: urinalysis indicating urine protein >= ++, or confirmed 24-hour urine protein >= 1.0 g; (6) Meeting any of the following cardiac findings: average corrected QT interval (QTc) > 470 msec derived from 3 electrocardiogram (ECG) recordings in resting state, with QT interval correction using the Fridericia formula (QTcF); resting ECG indicating various clinically significant rhythm, conduction, or ECG morphological abnormalities (e.g., complete left bundle branch block, 3rd-degree atrioventricular block, 2nd-degree atrioventricular block, and PR interval > 250 msec); presence of any factors increasing risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives under 40 years of age, or any concomitant medications that prolong QT interval; left ventricular ejection fraction (LVEF) = 140
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;R0 resection rate;event-free survival;overall survival;tissue Aspergillus burden;Pathological complete response rate;safety; | — |
Countries
China
Contacts
Public ContactZhentian Liu
Jiangxi Cancer Hospital
Outcome results
None listed