177Lu-AB-3PRGD2 in Patients With Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-AB-3PRGD2 in patients with Non Small Cell Lung Cancerr (NSCLC) who will undergo radioliagnd therapy using 177Lu-AB-3PRGD.

Detailed Description
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Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of NSCLC. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, provide an effective target for the treatment of NSCLC. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with single dose 1.11 GBq (30 mCi) of 177Lu-AB-3PRGD2 within one week. 1-2 ml venous blood was collected at 30min, 60min, 120min, 1d, 3d, 5d and 7d after administration to detect radioactivity count, respectively. Then monitored at 2, 24, 72, 120 and 168 h after 177Lu-AB-3PRGD2 administration with serial whole body planar and SPECT/CT imaging. Analyze and calculate the internal radiation dose of 177Lu-AB-3PRGD2 and evaluate its therapeutic efficiency and response.

Official Title
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Therapeutic Efficiency and Response to 177Lu-AB-3PRGD2 in Patients With Non Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: 1.11 GBq of 177Lu-AB-3PRGD2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed NSCLC patients; tumor lesions with high RGD untake confirmed on 68Ga-RGD PET/CT within one week before the injection of 177Lu-AB-3PRGD2; signed written consent. Exclusion Criteria: the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.11 GBq of 177Lu-AB-3PRGD2<br>The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-AB-3PRGD2 and underwent 68Ga-RGD PET/CT scans before and after the treatment. | Drug: 1.11 GBq of 177Lu-AB-3PRGD2<br>* accepted intravenous injection of 177Lu-AB-3PRGD2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| StandarStandardized uptake value of 177Lu-AB-3PRGD2 in normal organs and NSCLC. | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and NSCLC will be measured. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed. | 2 months |