About this trial
After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.
Eligibility criteria
Qualifiers
At the date of signing Informed Consent Form (ICF), 18 ~75 years old, male or female;
Expected survival time >3 months;
ECOG performance status 0-1;
Received preoperative neoadjuvant therapy (including PD-1 antibody);
Disqualifiers
A history of other malignant tumors within the past 5 years, excluding malignant tumors that can be expected to heal after treatment (including but not limited to well-treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);
Adverse reactions caused by previous treatments have not been recovered to grade ≤1 (CTCAE V6.0) (excluding alopecia and neurotoxicity, and hypothyroidism, adrenal insufficiency and hypopituitarism that cannot be restored to grade 2 as determined by the investigators for a long time);
Any immune-related adverse reaction (irAE) with a severity level greater than grade 3 that has occurred during any previous immunotherapy and has been permanently discontinued;
Have received vaccination within two months prior to signing the ICF, or plan to receive vaccination during the study;
Trial design
Treatments tested in this trial
- LM103 TILs Injection
- PD-1 / PD-L1 monoclonal antibody