Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-03 @ 11:38 AM
Study NCT ID:
NCT02917993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2016-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D007266', 'term': 'Inhibition, Psychological'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718170', 'term': 'itacitinib'}, {'id': 'C000603457', 'term': 'INCB039110'}, {'id': 'C000596361', 'term': 'osimertinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05561985', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Frequency, severity, and duration of adverse events (AEs)', 'timeFrame': 'From screening through 30-35 days after end of treatment, approximately 2 years.'}, {'measure': 'Phase 1: Number of subjects with dose-limiting toxicities (DLTs)', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Phase 2: Objective response rate (ORR) based on RECIST v1.1', 'timeFrame': 'Screening and 8-week intervals throughout the study, approximately 2 years.', 'description': 'ORR defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination', 'timeFrame': 'Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.'}, {'measure': 'Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC) of Itacitinib and osimertinib when administered in combination', 'timeFrame': 'Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.'}, {'measure': 'Phase 2: Depth of response (DpR) based on RECIST v1.1', 'timeFrame': 'Screening and 8-week intervals throughout the study, approximately 2 years.', 'description': 'Defined as the percentage of maximal tumor shrinkage observed at the lowest point (nadir) compared with baseline.'}, {'measure': 'Phase 2: Progression-free survival (PFS)', 'timeFrame': 'Interval from the first day of study treatment until disease progression or death due to any cause, approximately 3 years.'}, {'measure': 'Phase 2: Overall survival (OS)', 'timeFrame': 'Interval from the first day of study treatment until death due to any cause, approximately 3 years.'}, {'measure': 'Phase 2: Frequency, severity, and duration of AEs', 'timeFrame': 'From screening through 30-35 days after end of treatment, approximately 2 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'locally advanced', 'metastatic', 'epidermal growth factor receptor (EGFR) inhibition', 'Janus kinase inhibition'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://incyteclinicaltrials.com/studies/incb-39110-207', 'label': 'An Open-Label Phase 1/ 2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at screening; outside the U.S. and European Union, an older limit could apply depending on local regulation (eg, 19 years and older for South Korea and 20 years and older for Taiwan).\n* Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.\n* Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample. If a tissue sample is not available, then EGFR mutation status may be determined from circulating tumor DNA obtained from a blood sample using a validated or approved test kit.\n\n * Phase 1: Subjects must have previously received and progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). Additional lines of systemic therapy including investigational agents for locally advanced or metastatic NSCLC are allowed.\n * Phase 2: Subjects must not have received more than 1 prior line of therapy for locally advanced or metastatic NSCLC. First-line treatment must include an EGFR TKI, and subjects must have documented disease progression during or following treatment. Subjects with disease that progressed more than 6 months after completion of neoadjuvant/adjuvant chemotherapy or chemoradiation therapy are eligible if they received an EGFR TKI as first-line treatment for advanced NSCLC.\n\n * Subjects must have evidence of a T790M mutation in tumor tissue or plasma obtained after disease progression during or after treatment with an EGFR TKI. T790M mutation status from a local laboratory is acceptable; however, a tumor tissue sample or plasma sample suitable for centralized T790M mutation analysis must be available.\n* Radiographically measurable or evaluable disease per RECIST v1.1.\n\nExclusion Criteria:\n\n* Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may be eligible for the study, provided:\n\n * There is no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.\n * Subjects who are receiving corticosteroids must be on a stable or decreasing dose for at least 4 weeks before first dose of study treatment.\n* Laboratory parameters outside the protocol-defined range.\n* Clinically significant abnormalities found on an ECG.\n* Clinically significant or uncontrolled cardiac disease.\n* Past history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.\n* Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.\n* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or hormonal therapy).\n* Any previous use of Janus kinase (JAK) inhibitor, osimertinib, or other EGFR-directed therapy for T790M-mt NSCLC.'}, 'identificationModule': {'nctId': 'NCT02917993', 'briefTitle': 'An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'INCB 39110-207'}, 'secondaryIdInfos': [{'id': '2017-001750-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Itacitinib + osimertinib', 'interventionNames': ['Drug: Itacitinib', 'Drug: Osimertinib']}], 'interventions': [{'name': 'Itacitinib', 'type': 'DRUG', 'otherNames': ['INCB039110'], 'description': 'In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.', 'armGroupLabels': ['Itacitinib + osimertinib']}, {'name': 'Osimertinib', 'type': 'DRUG', 'description': 'Osimertinib 80 mg once daily (QD)', 'armGroupLabels': ['Itacitinib + osimertinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego, 3855 Health Sciences Drive, Mc 0987', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80124', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital, 3800 Reservoir Rd, NW', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Lynn Cancer Center, 701 NW 13th Street, Floor 2', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute, 450 Brookline Avenue', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System, 2799 W Grand Blvd.', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute, 4100 John R. street mail Code HW04HO', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Valley Hospital, 223 N Van Dien Avenue', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center, 160 East 34th Street, Floor 8', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center, 3 Edmund D. Pellegrino Road', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic, 9500 Euclid Avenue, G Building', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18015', 'city': 'Fountain Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's University Health Network, 701 Ostrum Street, Suite 403", 'geoPoint': {'lat': 40.60149, 'lon': -75.39518}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University, 111 S. 11th Street', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - South Austin, 901 West 38th Street, Suite 200', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - San Antonio Medical, 5206 Research Drive', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Tyler, 910 E Houston Street, Suite 100', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute, 2000 Circle of Hope Drive', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Cancer Institute, 1 Medical Center Drive', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho-gu', 'country': 'South Korea', 'facility': "The catholic University of Korea, Seoul St. Mary's hospital, 222 Banpo-daero", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seodaemun-gu', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System 50-1 Yonsei-ro', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center Department of Oncology, 88, Olympic-ro 43-gil', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Antiga Guarderia-Servei d'Oncologia Hospital Vall d'Hebron. P.Vall Hebron 119-129", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal Ctra. Colmenar Viejo Km. 9,1 Planta (-)2 Dcha Oficina de Ensayos Clínicos Servicio de Oncología Médica', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario Valencia Avenida Blasco Ibáñez 17 -8º', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '11217', 'city': 'Taipei', 'state': 'Beitou District', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital, No.201 Sec. 2 Shipai Rd l', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10002', 'city': 'Taipei', 'state': 'Zhongzheng District', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital, 7 Zhongshan South Road', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Peter Langmuir', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}