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99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

NCT02978196•Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Shanghai General Hospital

Shanghai, China

Key Dates

Start Date

February 15, 2018

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2022

Last Updated

May 17, 2024

Enrollment

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Injection of 99mTc-NM-01

PROCEDURE

Injection of 68Ga-NM-01

PROCEDURE

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)