Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-05 @ 1:16 PM
Study NCT ID:
NCT06973161
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Anticipated to be approximately 11 to 17 months', 'description': 'Time from the date of first dose of treatment until the date of death due to any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Bladder Cancer', 'Biliary Tract Cancer', 'Cervical Cancer', 'Endometrial Cancer', 'Ovarian Cancer', 'Pancreatic Cancer', 'Colorectal Cancer', 'Lung Cancer', 'Other Tumors']}, 'descriptionModule': {'briefSummary': "In DESTINY-Pan-Tumor \\[DP-02\\], DESTINY CRC02 \\[DC-02\\], and DESTINY-Lung01 \\[DL-01\\], T-DXd demonstrated tumor response across a broad range of HER2-expressing solid tumors, particularly IHC3+ patients.\n\nThis study will use real-world data (RWD) to identify IHC3+ patients in the real world who received standard of care (SoC) and compare them with IHC3+ patients who received T-DXd in the referent trials. The tumors included are: non-small cell lung cancer \\[NSCLC\\], colorectal cancer \\[CRC\\], endometrial cancer, bladder cancer, epithelial ovarian cancer, cervical cancer, pancreatic cancer, biliary tract cancers, and other tumors.\n\nThis is a real-world external control arm (ECA) study to generate evidence on the comparative effectiveness of T-DXd versus real-world (RW) SoC in adult patients with HER2 IHC3+ solid tumors who have received prior systemic treatment. HER2 IHC3+ patients who initiated 5.4mg/kg of T-DXd in the referent trials (DP-02, DC-02, and DL-01) will be compared against IHC3+ patients who received RW SoC. This will be a retrospective observational study which will use secondary real-world data and data collected in the 3 aforementioned trials.\n\nObjectives: The primary objective of this study is to evaluate the comparative effectiveness with respect to overall survival (OS) for T-DXd vs SoC for patients with HER2 IHC3+ expressing solid tumors in two pooled cohorts: one cohort reflecting the tumors in the three referent trials (referred to as the 'tumor agnostic' cohort), consisting of patients with NSCLC, CRC, endometrial, epithelial ovarian, cervical, pancreatic, biliary tract cancers, and other tumors; and a second cohort reflecting the tumors in the DP-02 trial (referred to as 'pan tumor'), consisting of the same tumors but excluding NSCLC and CRC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population of interest is adult patients with HER2 IHC3+ unresectable and/or metastatic disease falling within the indications of interest. All IHC3+ patients who initiated 5.4 mg/kg of T-DXd in DP-02, DC-02, or DL-01 for each indication will be included in the T-Dxd arm of this study. To identify RW SoC patients for each indication, relevant eligibility criteria from the corresponding referent trial will be applied and modified for the RW setting where required.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (for the ECA):\n\nMale or female patients aged 18 years or older at the time of locally advanced, unresectable or metastatic disease diagnosis.\n\nPatients diagnosed with one of the following malignancies:\n\nLocally advanced, unresectable or metastatic colorectal adenocarcinoma, biliary tract, bladder (urothelial), cervical, endometrial, epithelial ovarian, pancreatic, or other solid tumors, or unresectable and/or metastatic non-squamous NSCLC.\n\nPatients may be included on the basis of de-novo locally advanced, unresectable or metastatic disease diagnosis or progression from initial diagnosis at earlier stages.\n\nPatients must have received at least one line of prior systemic anti-cancer therapy (SACT) therapy in the advanced/ unresectable/ metastatic setting (i.e. excluding adjuvant/ neoadjuvant SACT) prior to index.\n\nIndex date (start of 2nd or later line SoC systemic anti-cancer therapy (SACT) treatment) for advanced disease occurring between January 2017 and December 2022.\n\n\\[CRC patients only\\] Prior treatment at index with at least one of the following in prior lines of therapy:\n\nFluoropyrimidine, oxaliplatin, and irinotecan\n\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type\n\nAnti-vascular endothelial growth factor (VEGF) treatment\n\nAnti-programmed death-ligand 1 (PD-\\[L\\]-1) therapy if tumor is microsatellite instable (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high\n\n\\[CRC patients only\\] BRAF wild-type cancer and confirmed RAS status (either mutant or wild type) identified through testing of the primary tumor or metastatic site at any time following initial diagnosis.\n\nIHC3+ HER2-expression confirmed through testing of tumor samples taken in the advanced/ recurrent/ metastatic disease stage. The sample taken closest in time prior to the or at start of the index line of therapy should be used to confirm IHC3+ HER2 status. Positive IHC3+ tests may be the result of testing at the time of sampling by the sites or retrospective testing based on archival tumor samples\n\nECOG of 0 or 1 (or Karnofsky score of ≥ 70%8), or missing performance status based on most recently recorded information prior to or at index date.\n\nPatients without recorded history of liver disease, leukaemia, aplastic anaemia or haemophilia at index date.\n\nPatients known to have died must have a complete recorded date of death.\n\nExclusion Criteria (for the ECA):\n\nRecord of other primary malignancies (except non-melanoma skin cancer) at any time prior to or after index.\n\nRecord of spinal cord compression prior to or at index or active CNS metastases at index (with active CNS metastases determined per physician judgment OR receipt of radiotherapy directed at CNS metastases within 6 months prior to index).\n\nRecord of myocardial infarction within 6 months prior to index date or congestive heart failure at any time prior to or at index date.\n\nRecord of lung-specific intercurrent clinically significant illness based on physician judgement prior to or at index date.\n\nHistory of (non-infectious) ILD/ pneumonitis prior to or at index.\n\nRecord of autoimmune, connective tissue or inflammatory disorders prior to or at index date.\n\nRecord of complete pneumonectomy prior to or at index date.\n\nPresence of systemic infection at index date.\n\nRecord of HIV prior to or at index date, or active Hep B or Hep C infection at index date.\n\nTreatment with T-DXd or DXd-containing ADC at any time prior to or at index.\n\nRecord of pregnancy at or at any time following advanced/ unresectable/ metastatic disease diagnosis.\n\nTreatment as part of a clinical trial at any time prior to or at index.\n\n\\[Pan-tumor patients only\\] Patients with a record of pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART) at index.\n\n\\[Colorectal patients only\\] Patients with record of leptomeningeal carcinomatosis prior to or at index.\n\n\\[NSCLC patients only\\] Treatment with a HER2-targeted therapy (except for pan-HER class tyrosine kinase inhibitors) at any time prior to or at index.\n\n\\[NSCLC patients only\\] Record of unstable angina at any time prior to or at index date.'}, 'identificationModule': {'nctId': 'NCT06973161', 'briefTitle': 'ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors (ESPERANZA)', 'orgStudyIdInfo': {'id': 'D967VR00001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Systemic Anticancer Therapy', 'description': 'Patients who received the existing standard of care systemic anti-cancer therapy (SACT) per routine clinical practice in the real-world setting.'}, {'label': 'Trastuzumab Deruxtecan', 'description': 'Patients who received 5.4 mg/kg trastuzumab deruxtecan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'N6A 5A5', 'city': 'London, Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Olomouc', 'status': 'NOT_YET_RECRUITING', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Copenhagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'W Rzburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Meldola', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Research Site', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.\n\nSigned Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, {'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}