Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT06275360
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repositioning Immunotherapy in VetArans With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Approximately two years after enrollment', 'description': 'Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.'}, {'measure': 'Treatment Tolerance', 'timeFrame': 'Approximately three years after enrollment', 'description': 'Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Approximately two years after enrollment', 'description': 'Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution.'}, {'measure': 'Best overall response rate (BOR)', 'timeFrame': 'Approximately two years after enrollment', 'description': 'Defined as the proportion of participants who achieve a confirmed either a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by central review.'}, {'measure': 'Overall survival', 'timeFrame': 'Approximately two years after enrollment', 'description': 'Defined as the time from start of treatment to the date of death from any cause..'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be more than 18 years of age.\n* Patient must have a performance status of 0-1 (ECOG Performance Scale).\n* Patient must be a candidate for concurrent chemoradiation.\n* Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment\n* PD-L1 tumor expression greater than or equal to 1%\n* Presence of measurable disease according to RECIST v1.1\n* Adequate organ function\n* Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity).\n\nExclusion Criteria:\n\n* Active autoimmune disease that has requires immunosuppressive therapy in the previous year.\n* Uncontrolled primary or acquired immunodeficiency (including HIV)\n* Baseline corticosteroid usage (\\>10 mg prednisone or equivalent daily) aside from supportive medication use.\n* Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions.\n* Presence of significant comorbidities precluding participation in a clinical study as determined by investigator.\n* Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment.\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Has known active Hepatitis B or Hepatitis C.\n* Has received a live vaccine within 30 days of enrollment.\n* Known diagnosis of Interstitial Lung Disease\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06275360', 'acronym': 'RIVAL', 'briefTitle': 'Repositioning Immunotherapy in VetArans With Lung Cancer', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Repositioning Immunotherapy in Veterans With Lung Cancer', 'orgStudyIdInfo': {'id': 'SPLP-002-23F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemoimmunotherapy followed by radiotherapy', 'description': 'Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy', 'interventionNames': ['Drug: Nivolumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': 'Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)', 'armGroupLabels': ['Chemoimmunotherapy followed by radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073-1003', 'city': 'West Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Shin, MD', 'role': 'CONTACT', 'email': 'Daniel.Shin@va.gov', 'phone': '310-478-3711'}, {'name': 'Michelle Treadwell', 'role': 'CONTACT', 'email': 'Michelle.Treadwell@va.gov', 'phone': '3104783711', 'phoneExt': '45003'}], 'facility': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}, {'zip': '06516-2770', 'city': 'West Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michal Rose, MD', 'role': 'CONTACT', 'email': 'Michal.Rose@va.gov', 'phone': '203-932-5711', 'phoneExt': '2832'}, {'name': 'Alicia Roy', 'role': 'CONTACT', 'email': 'Alicia.Roy@va.gov', 'phone': '2039325711', 'phoneExt': '3006'}], 'facility': 'VA Connecticut Healthcare System West Haven Campus, West Haven, CT', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '48105-2303', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brittany M Pannecouk, BS', 'role': 'CONTACT', 'email': 'brittany.pannecouk@va.gov', 'phone': '734-845-3966'}, {'name': 'Laura A Randolph, BA', 'role': 'CONTACT', 'email': 'Laura.Randolph@va.gov', 'phone': '(734) 845-5091'}, {'name': 'Michael D Green', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nithya Ramnath, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '68105-1850', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Apar Kishor P Ganti, MD', 'role': 'CONTACT', 'email': 'Aparkishor.Ganti@va.gov', 'phone': '402-346-8800', 'phoneExt': '3846'}, {'name': 'Anna Kellogg', 'role': 'CONTACT', 'email': 'Anna.Kellogg@va.gov', 'phone': '4029954143'}], 'facility': 'Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27705-3875', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Kelley, MD', 'role': 'CONTACT', 'email': 'Michael.Kelley6@va.gov', 'phone': '919-286-0411', 'phoneExt': '172199'}, {'name': 'Maya Robinson', 'role': 'CONTACT', 'email': 'Maya.Robinson@va.gov', 'phone': '9192866926'}], 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106-1702', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Nock, MD', 'role': 'CONTACT', 'email': 'Charles.Nock@va.gov', 'phone': '216-791-3800', 'phoneExt': '64825'}, {'name': 'Margaret Titkin', 'role': 'CONTACT', 'email': 'MargaretTiktin@va.gov', 'phone': '2167913800', 'phoneExt': '36241'}], 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '23249-0001', 'city': 'Richmond', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bhaumik Patel, MD', 'role': 'CONTACT', 'email': 'Bhaumik.Patel@va.gov', 'phone': '804-675-5446'}], 'facility': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Nithya Ramnath, MD', 'role': 'CONTACT', 'email': 'nithya.ramnath@va.gov'}, {'name': 'Garth W Strohbehn, MD MSc', 'role': 'CONTACT', 'email': 'garth.strohbehn@va.gov', 'phone': '(734) 769-7100', 'phoneExt': '55061'}], 'overallOfficials': [{'name': 'Michael D Green', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Nithya Ramnath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}