Non-small cell lung cancer
Conditions
Interventions
One:Neoadjuvant immunotherapy combined with chemotherapy
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histopathologically diagnosed with non-small cell lung cancer as the accepted diagnostic criterion; 2.Age>=65 years, ECOG score 0-2; 3.After a comprehensive examination and evaluation of the patient's lesions and major organ functions, the patient was confirmed as stage IIA-IIIB resectable elderly NSCLC and suitable for neoadjuvant immunotherapy combined with chemotherapy, and the patient voluntarily participated in this study, had good compliance, cooperated with follow-up, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Mixed SCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma confirmed by histology or cytology; 2.Patients who have previously received any antitumor treatment, including radiotherapy, chemotherapy, or immunotherapy; 3.Patients confirmed by genetic testing to have positive driver gene mutations such as EGFR or ALK; 4.High-risk populations who may have poor tolerance to or response to immunotherapy, including: patients with any active autoimmune disease or a history of autoimmune disease, or patients with congenital or acquired immunodeficiency; patients with severe cardiovascular or cerebrovascular disease or other important organ dysfunction, or subjects with known or suspected interstitial pneumonia; patients known to have allergic reactions, hypersensitivity, or intolerance to immunotherapy, chemotherapy drugs, or their excipients; 5.Patients currently participating in other clinical studies; 6.Any condition that the investigator believes may harm the subject or prevent the subject from meeting or complying with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of severe adverse events;Surgery delay rate and completion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ppathological efficacy (pCR/MPR rate);Long-term efficacy (DFS/OS);The impact of neoadjuvant therapy on surgery; | — |
Countries
China
Contacts
Public ContactZhiqiang Xue
The First Medical Center of PLA General Hospital
Outcome results
None listed