Non-small cell lung cancer
Conditions
Interventions
Real-world treatment group:None
Follow-up Group (pCR Group):Neoadjuvant treatment: adebrelimab 20 mg/kg IV on day 1 every 3 weeks for 3 cycles in combination with platinum-based chemotherapy. Non-squamous NSCLC: pemetrexed 500 mg/m^
squamous NSCLC: paclitaxel 175 mg/m^2 plus carboplatin AUC 5 IV on day 1 every 3 weeks (carboplatin dose [mg] = target AUC 5 mg·min/mL × [creatinine clearance (mL/min) + 25]). Surgery is performed 4–6
patients receive routine follow-up only.
Maintenance-Therapy Group (non-pCR Group):Neoadjuvant treatment: adebrelimab 20 mg/kg IV on day 1 every 3 weeks for 3 cycles in combination with platinum-based chemotherapy. Non-squamous NSCLC: pemetr
squamous NSCLC: paclitaxel 175 mg/m^2 plus carboplatin AUC 5 IV on day 1 every 3 weeks. Surgery is performed 4–6 weeks after the last adebrelimab dose. At 4–6 weeks postoperatively, non-pCR patients r
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent: (1) The subject must have signed the ethics committee-approved informed consent form in accordance with regulatory requirements and institutional guidelines; (2) The subject must be willing and able to comply with scheduled visits, treatment protocols, and laboratory tests; 2. Subject type and disease characteristics: (1) Male or female aged >=18 years and =2 weeks prior to surgery; (8) Expected survival >=12 weeks; (9) Must have undergone the following imaging studies prior to surgery or enrollment, as standard of care: contrast-enhanced CT of chest and abdomen (including adrenals and liver) and bone scan or whole-body PET/CT, with imaging completed within 28 days prior to surgery; 3. Organ function status: (1) Adequate hematologic parameters: absolute neutrophil count (ANC) >=1.8×10^9/L, platelet count >=100×10^9/L, hemoglobin >=9 g/dL; (2) Adequate liver function: total bilirubin =60 mL/min.
Exclusion criteria
Exclusion criteria: 1. Active hepatitis B. Active hepatitis B is defined as: HBsAg-positive with HBV-DNA copy number >= the upper limit of normal specified by the central laboratory of the study site; 2. History of or current clinical active interstitial lung disease. Current active pneumonia. Current radiation pneumonitis requiring corticosteroid therapy; 3. Dysphagia, active gastrointestinal disease, or other conditions significantly affecting absorption, distribution, metabolism, or excretion of the study drug. History of subtotal gastrectomy; 4. Known HIV antibody-positive status, or presence of other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 5. Clinically significant active infection, including active tuberculosis; 6. Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric or neurological disorders, epilepsy, or dementia; unstable or decompensated respiratory, cardiovascular, hepatic, or renal disease; uncontrolled hypertension [defined as diastolic blood pressure >=100 mmHg and/or systolic blood pressure >=160 mmHg despite pharmacologic treatment]); 7. Myocardial infarction, coronary or peripheral arterial bypass, or cerebrovascular accident within the past 3 months; 8. Diagnosis of another malignancy within the past 5 years, excluding completely resected basal cell carcinoma, in situ bladder cancer, or in situ cervical cancer; 9. Known hypersensitivity to any component or excipient of the study drug; exclusion from enrollment; 10. Prior local treatment targeting the target lesion, including radiotherapy or ablation; 11. Prior local treatment of lymph nodes, such as radiotherapy or ablation; 12. Surgical specimens confirmed to have histological components of mixed small cell, neuroendocrine tumor, sarcomatoid carcinoma, or large cell carcinoma; exclusion required; 13. Any of the following cardiac criteria: (1) Resting ECG with QTc interval >470 msec; (2) Any clinically significant abnormality in ECG rhythm, conduction, or morphology, such as complete left bundle branch block, third-degree heart block, or second-degree heart block; (3) Any factor increasing risk of QTc prolongation or arrhythmic events, including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or first-degree relative with unexplained sudden death under age 40, or concomitant use of any drug known to prolong the QT interval; 14. Use of known strong CYP3A4 inducers or herbal supplements within the past 2 weeks, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nevirapine, nelfinavir, ritonavir, saquinavir, telithromycin, dirithromycin, voriconazole, grapefruit, or grapefruit juice; 15. Women who are breastfeeding; 16. Women of childbearing potential during screening without a negative serum or urine pregnancy test. Absence of childbearing potential is defined as at least 1 year post-menopause, or surgical sterilization, or hysterectomy. All enrolled patients (male or female) must agree to use contraception throughout the treatment period and for 3 months after treatment completion; 17. Participation in any drug clinical trial within the past 6 months prior to screening; 18. Patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Major pathological response rate;Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhou Haiyu
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed