protocolSection identificationModule nctId: NCT06346392, orgStudyIdInfo id: D9802C00001, briefTitle: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-04-10, completionDateStruct date: 2026-10-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2., conditionsModule conditions: Gastric Cancer, conditions: Gastroesophageal Junction Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized in a 1:1:1 ratio to one of the following intervention arms until the dose selection decision is made:Arm 1: AZD0901 arm 1 IV, Q3W Arm 2: AZD0901 arm 2 IV, Q3W Arm 3: Participants in the Investigator's choice arm, including regionally accepted chemotherapies or targeted therapies 2L: Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W 2L: Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only) 2L: Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only) 3L+: Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W 3L+: TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China) 3L+: Apatinib 500-850 mg, orally once daily, Q4W (China only), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is an open-label study; however, it will be conducted 'sponsor-blind' and the specific treatment to be taken by a participant will be assigned using an IRT/RTSM. To maintain the integrity of the study, sponsor access to treatment records will be restricted, and, in particular, under no circumstances will the sponsor undertake any efficacy analysis by treatment arm during the study. A Study Integrity Plan will be generated in which nominated individuals who will be granted access to any treatment-revealing data will be pre-specified, with their reason for requiring access detailed., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 589, type: ESTIMATED, armsInterventionsModule interventions name: AZD0901, interventions name: AZD0901, interventions name: Ramucirumab+ paclitaxel, interventions name: Paclitaxel, interventions name: Docetaxel, interventions name: Irinotecan, interventions name: TAS-102, interventions name: Apatinib, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) in all randomized participants, primaryOutcomes measure: Overall Survival (OS) for 3L+ participants, secondaryOutcomes measure: OS in all randomized participants, secondaryOutcomes measure: PFS for 3L+ participants, secondaryOutcomes measure: Objective Response Rate (ORR) in all randomized participants, secondaryOutcomes measure: ORR for 3L+ participants, secondaryOutcomes measure: Duration of Response (DoR) in all randomized participants, secondaryOutcomes measure: Serum concentrations of AZD0901, total antibody and MMAE, secondaryOutcomes measure: Status of ADA to AZD0901, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs, secondaryOutcomes measure: PK parameters (such as peak concentration, as data allow) of AZD0901, total antibody and MMAE, secondaryOutcomes measure: PK parameters (such as trough concentration, as data allow) of AZD0901, total antibody and MMAE, secondaryOutcomes measure: Prevalence and incidence of ADA to AZD0901, secondaryOutcomes measure: Titer of ADA to AZD0901, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Research Site, status: WITHDRAWN, city: Santa Rosa, state: California, zip: 95403, country: United States, geoPoint lat: 38.44047, lon: -122.71443, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Marietta, state: Georgia, zip: 30060, country: United States, geoPoint lat: 33.9526, lon: -84.54993, locations facility: Research Site, status: WITHDRAWN, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64111, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Site, status: WITHDRAWN, city: Saint Louis, state: Missouri, zip: 63110, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saint Louis, state: Missouri, zip: 63128, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mineola, state: New York, zip: 11501, country: United States, geoPoint lat: 40.74927, lon: -73.64068, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19111, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Charlottesville, state: Virginia, zip: 22908, country: United States, geoPoint lat: 38.02931, lon: -78.47668, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 4N2, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Barrie, state: Ontario, zip: L4M 6M2, country: Canada, geoPoint lat: 44.40011, lon: -79.66634, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, state: Ontario, zip: N6C 2R5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ottawa, state: Ontario, zip: K1H 8L6, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100210, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: RECRUITING, city: Chengdu, zip: 610000, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610042, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fuzhou City, zip: 350001, country: China, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fuzhou, zip: 350014, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Research Site, status: RECRUITING, city: Guangzhou, zip: 510060, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: 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country: China, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tianjin, zip: 300060, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Urumqi, zip: 830000, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuhan, zip: 430000, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuhan, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xi'an, zip: 710061, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zhengzhou, zip: 450003, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Besançon Cedex, zip: 25030, country: France, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brest, zip: 29200, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lyon, zip: 69008, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nantes, zip: 44000, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Research Site, status: NOT_YET_RECRUITING, city: PARIS Cedex 12, zip: 75571, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Research Site, status: 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lon: -3.10293, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hanoi, zip: 100000, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ho Chi Minh city, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vinh, zip: 460000, country: Vietnam, geoPoint lat: 18.67337, lon: 105.69232, hasResults: False