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PD-L1 Expression in Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

PD-L1 Expression in Lung Cancer

A Single-arm, Phase II Study to Evaluate PD-L1 Expression in Non-Small Cell Lung Cancer Using the 99mTc Labelled Anti-PD-L1 Single Domain Antibody (NM-01)

NCT04992715•NanoMab Technology (UK) Limited

View on ClinicalTrials.gov

Summary

This study will measure PD-L1 expression in metastatic NSCLC (primary tumour and metastatic lesions) using \[99mTc\]-NM-01 SPECT/CT and compare to PD-L1 percentage expression determined by immunohistochemistry (IHC).

Detailed Description

A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 or above
•Patients with histopathology confirmed untreated metastatic NSCLC scheduled for systemic anti-cancer therapy
•ECOG status ≤ 1
•Willingness and ability to comply with scheduled study visits and tests

Exclusion Criteria

•Pregnant or breast-feeding women
•Concomitant uncontrolled medical conditions as per Investigator assessment
•\> 3 months between IHC PD-L1 and study recruitment
•Significant abnormality of haematology (one or more of: Hb ≤ 90g/L, absolute neutrophil count (ANC) ≤1.5 x109/L, platelet count ≤75 x109/L)
•Significant abnormality of renal function (defined as Cockcroft-Gault calculated creatinine clearance ≤30 mL/min)
•Significant abnormality of liver function (one or more of: AST or ALT ≥2.5x ULN or ≥ 5x ULN if patient has liver metastases; total bilirubin ≥1.5xULN. In the case of patients with Gilbert's syndrome then direct bilirubin must be confirmed as ≤ ULN)
•Significant cardiovascular disease, including New York Heart Association (NYHA) heart failure ≥Class III, myocardial infarction within 3 months of enrolment, unstable arrhythmia or unstable angina
•History of uncontrolled allergic reactions and/or have hypersensitivity to anti-PD-L1 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity

Locations (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Key Dates

Start Date

May 3, 2022

Primary Completion Date

September 1, 2023

Completion Date

September 1, 2023

Last Updated

March 22, 2023

Enrollment

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

[99mTc]-NM01 SPECT/CT

DIAGNOSTIC_TEST

Contacts

Gary JR Cook

CONTACT

(0044)20 7188 7188 ext 88378 gary.cook@kcl.ac.uk

Honghoi Ting

CONTACT

hhting@nano-mab.com

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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RECRUITINGPHASE3

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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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: March 22, 2023Data 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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PD-L1 Expression in Lung Cancer

Inclusion Criteria

Exclusion Criteria

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

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)

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)