protocolSection identificationModule nctId: NCT06305962, orgStudyIdInfo id: 177Lu-RAD204.2023.0001, briefTitle: 177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Radiopharm Theranostics, Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests., conditionsModule conditions: PDL1 Gene Mutation, conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-RAD204, outcomesModule primaryOutcomes measure: Time Activity Curves (TACs), primaryOutcomes measure: Radiation dosimetry of Lu177-RAD204im, primaryOutcomes measure: Pharmacokinetics of 177Lu-RAD204im, primaryOutcomes measure: Biokinetics of 177Lu-RAD204im, primaryOutcomes measure: Safety and tolerability of 177Lu-RAD204tr, primaryOutcomes measure: Recommended dose(s) of 177Lu-RAD204tr for future exploration, secondaryOutcomes measure: Safety and tolerability of a single dose of 177Lu-RAD204im, secondaryOutcomes measure: Recommended dose(s) of 177Lu-RAD204im for future exploration, secondaryOutcomes measure: Preliminary antitumor activity of 177Lu-RAD204tr, secondaryOutcomes measure: Radiation dosimetry of 177Lu-RAD204tr, otherOutcomes measure: Level of agreement between 177Lu-RAD204im and standard of care imaging, otherOutcomes measure: Effect of 177Lu-RAD204im and 177Lu-RAD204tr on tumor markers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Princess Alexandra Hospital, status: RECRUITING, city: Woolloongabba, state: Queensland, zip: 4102, country: Australia, contacts name: Kenneth O'Byrne, MD, role: CONTACT, phone: +610449091958, email: kenneth.obyrne@health.qld.gov.au, geoPoint lat: -27.48855, lon: 153.03655, locations facility: Hollywood Private Hospital, status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Joe Cardaci, MD, role: CONTACT, phone: 0893862844, email: jcardaci@dni.com.au, geoPoint lat: -31.98184, lon: 115.8073, hasResults: False