Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
PROCEDUREInjection of 99mTc-NM-01
Patient is injected with micro-dose of 99mTc-NM-01
PROCEDUREInjection of 68Ga-NM-01
Patient is injected with micro-dose of 68Ga-NM-01
Sponsors
NanoMab Technology (UK) Limited
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Assessment of PD-L1 expression in NSCLC using 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET/CT Scan | 1 year | Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99mTc-NM-01 and 68Ga-NM-01 in lung lesions. A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher. |
| Semiquantitative Assessment of Lung Lesions in 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET Scan | 1 year | Patients in the 99mTc-NM-01 group will be administered 3-12 MBq/kg of 99mTc-NM-01 and patients in the 68Ga-NM-01 group will be administered 0.75-4 MBq/kg of 68Ga-NM-01. The semiquantitative analysis of the region of interest (ROI) will be performed in lung lesions. Higher level of PD-L1 expression (Tumor proportion score, TPS), higher ROI in tumor. No expression TPS \< 1%; Low expression TPS 1 - 49%; High expression TPS ≥ 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD-L1 expression levels | 1 year | Patients biopsy sample will be tested to confirm the levels of PD-L1 expression using Human PD-L1 ELISA Kit. |
| Adverse Drug Reaction Report | 7 days | Monitor adverse events within 7 days after the injection and scanning to establish the safety of 99mTc-NM-01 and 68Ga-NM-01 in patients. |
| New tumor lesion detection | 1 year | 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET/CT may detect new tumor areas, which can be further proven by biopsy method in order to rule out any false positive results. |
Countries
China
Outcome results
None listed