99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC

99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of Programmed Death Ligand-1 Expression in Non-small Cell Lung Cancer

To evaluate the safety, dosimetry and efficacy of 99mTc/68Ga labeled anti-PD-L1 single domian antibody (sdAb) (Product Code Name: 99mTc-NM-01 and 68Ga-NM-01) in the diagnostic imaging PD-L1 expression in Non-Small Cell Lung Cancer (NSCLC) and compare it with the existing gold standard "biopsy PD-L1 detection". It is also to establish a new clinical method of non-invasive PD-L1 expression detection in NSCLC using 99mTc/68Ga labeled anti-PD-L1 sdAb.

Inclusion Criteria:

• Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
• Male or female, aged 18-75 years old
• Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests
• AST, ALT, BUN, Cr not more than double the normal values
• Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases

Exclusion Criteria:

• Severe infection
• Unable to provide biopsy sample for testing PD-L1 expression level
• Patients with pacemakers
• Pregnant and lactating women
• Investigators professional decision that the subject should not participate in this clinical study