Non-small cell lung cancer, NSCLC
Conditions
Interventions
Experimental group:Ivocilimab combined with chemotherapy
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age on the date of informed consent (or the legal age in the jurisdiction where the study was conducted) 2, ECOG performance status 0 or 1 3. Patients with histologically confirmed stage IB (=4cm)-IIIA NSCLC (according to AJCC 7th edition) received three cycles of neoadjuvant therapy with ivocizumab plus platinum-based doubled-agent chemotherapy, and the efficacy and safety of this regimen were evaluated. The study included two cohorts. Cohort 1 included patients who were negative for driver genes (EGFR, ALK, or ROS1 sensitive mutations). Cohort 2 consisted of patients with EGFR mutations. During the screening period, treatment period (including neoadjuvant period and surgery), safety follow-up period and survival follow-up period, postoperative adjuvant therapy could be selected according to the follow-up stage. 4. Measurable disease as assessed by the investigator according to RECIST, version 1.1 5. After evaluation by the thoracic surgeon, it was confirmed that the requirements for R0 resection for the purpose of radical treatment were met 6. Cardiopulmonary function is good, confirming that the requirements for surgical resection for the purpose of radical treatment are met 7. Eligible to receive platinum-based doubtless chemotherapy 8. Good blood and end-organ function, as defined by laboratory test results obtained within 14 days before randomization, as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Any previous treatment for current lung cancer, including chemotherapy or radiotherapy 2. Patients with large cell neuroendocrine carcinoma (LCNEC) 3. The presence of locally advanced unresectable disease (regardless of disease stage), and metastatic disease (stage IV). In patients with mediastinal lymph-node involvement assessed by CT scan, samples of four (bilateral) levels of mediastinal lymph nodes were required to determine clinical stage to exclude stage IIIB disease. 4. A right pneumonectomy was planned. Previous or current history of other malignant tumors, excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix; 5. A history of interstitial lung disease requiring steroid therapy, drug-induced interstitial disease, radiation pneumonitis, or evidence of any active interstitial lung disease; 6. Meet any of the following cardiac criteria: - Mean resting corrected QT interval (QTc) >470 ms on three electrocardiograms (ECGs) - any clinically important abnormalities in heart rhythm, conduction, or resting ECG morphology, such as complete left bundle branch block, third-degree heart block, and second-degree heart block Patients had any factors that increased the risk of a prolonged QTc interval or arrhythmic events, such as heart failure, electrolyte abnormalities (including serum/plasma potassium <LLN, serum/plasma magnesium <LLN, and serum/plasma calcium <LLN), congenital long QT syndrome, family history of long QT syndrome, or 40 Sudden unexplained death of a first-degree relative under the age of 10 years or any concomitant medication known to prolong the QT interval and cause torsades de pointes * Electrolyte abnormalities can be corrected to normal ranges during screening. 7. Idiopathic pulmonary fibrosis confirmed by CT scan at baseline; 8. Any chronic toxicity of CTCAE grade 2 or above that has not recovered after previous anti-tumor therapy; 9. Any serious or uncontrolled systemic disease as judged by the investigator (e.g., unstable or decompensated respiratory/cardiovascular/liver/kidney disease); 10. Any other significant clinical or laboratory abnormality that precludes the patient from participating in a clinical study; 11. Pregnancy or lactation; 12. The investigator determined that the patient could not tolerate chemotherapy combined with ivocximab treatment; 13. Life expectancy <=12 weeks; 14. Use of an unapproved drug or study drug within 30 days before the start of the study; 15. Any evidence of severe and uncontrolled systemic illness, including uncontrolled hypertension and a tendency to active bleeding (which the investigator considered to preclude participation in the trial or might interfere with protocol adherence), or active infection, such as any patient treated for infection, These include uncontrolled active hepatitis C and human immunodeficiency virus (HIV), or uncontrolled HBV infection; 16. There is no need for chronic disease screening. Patients with hepatitis B infection were eligible if they met the following criteria: HBV-DNA=100IU per milliliter. No co-infection with hepat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the blinded independent central pathology laboratory review (BIPR) rate of significant pathologic response (MPR) in patients who received ivocilimab plus platinum-doublet chemotherapy as neoadjuvant therapy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Overall survival, OS ;Pathological complete response rate;Objective response rate;Incidence and severity of TEAE;Health-related quality of life, HRQoL; | — |
Countries
China
Contacts
Public ContactChen Lijuan
Henan Cancer Hospital
Outcome results
None listed