Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 9:25 AM
Study NCT ID:
NCT06498635
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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': 'D013048', 'term': 'Specimen Handling'}, {'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D004220', 'term': 'Disulfides'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'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'}, {'id': 'D013440', 'term': 'Sulfides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006862', 'term': 'Hydrogen Sulfide'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2039-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient reported outcomes', 'timeFrame': 'Up to 10 years', 'description': 'Will be assessed by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument(s). For each of the PRO-CTCAE adverse events examined, the scores for each attribute (frequency, severity and/or interference) will be presented descriptively using summary statistics at each assessment time. Additionally, the worst severity and/or interference over the entire course will be summarized.'}, {'measure': 'Estimates of the primary outcome treatment effect', 'timeFrame': 'Up to 10 years', 'description': 'The hazard ratio of DFS and the corresponding 95% CIs will be estimated for subgroups defined by sex, race and ethnicity, respectively.'}], 'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'From date of randomization to the earliest event defined as date of first documentation of recurrence, any new lung cancer (even in the contralateral lung), or death due to any cause, assessed up to 10 years', 'description': 'Will be assessed using a 1-sided 5% level log-rank test accounting for interim testing, stratified on the randomization stratification factors.'}], 'secondaryOutcomes': [{'measure': 'Event-free survival (EFS)', 'timeFrame': 'From date of randomization to date of first occurrence of EFS event, assessed up to 10 years', 'description': 'EFS events are defined as: Discontinuation of durvalumab (MEDI4736) due to toxicity, either immune or non-immune related, any new lung cancer (even in the contralateral lung), the use of glucocorticoids for \\> 14 days for the treatment of toxicity secondary to durvalumab (MEDI4736), hospitalization due to toxicity from durvalumab (MEDI4736), disease recurrence, or death due to any cause. Will be estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. Hazard ratios (HRs) and corresponding 90% confidence intervals (CI) will be estimated using a Cox proportional hazards model with treatment arm as a single covariate. EFS will be compared between treatment arms using log-rank test, stratified on the randomization stratification factors.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From date of randomization to date of death due to any cause, assessed up to 10 years', 'description': 'Will be estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. HRs and corresponding 90% CI will be estimated using a Cox proportional hazards model with treatment arm as a single covariate. OS will be compared between treatment arms using log-rank test, stratified on the randomization stratification factors.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 10 years', 'description': 'Will be evaluated using the Common Terminology Criteria for Adverse Events version 5 items. Binary proportions and associated confidence intervals will be calculated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Non-Small Cell Carcinoma', 'Stage II Lung Cancer AJCC v8', 'Stage IIIA Lung Cancer AJCC v8', 'Stage IIIB Lung Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': "This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To compare disease free survival (DFS) in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response (pCR) following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab (MEDI4736) versus surveillance.\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall survival (OS) between the arms. II. To evaluate the frequency and severity of toxicities of adjuvant durvalumab (MEDI4736).\n\nIII. To compare the event free survival (EFS) between the arms.\n\nTRANSLATIONAL MEDICINE OBJECTIVE:\n\nI. To bank specimens and images for additional future translational medicine studies.\n\nQUALITY OF LIFE (QOL) PRIMARY OBJECTIVE:\n\nI. To compare patient-reported quality of life (QOL) status between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Lung (FACT-L) Trial Outcome Index (TOI).\n\nQOL SECONDARY OBJECTIVES:\n\nI. To compare patient-reported QOL between treatment arms at 24 weeks (6 months) from randomization using the Functional Assessment of Cancer Therapy-Biologic Response Modifier (FACT-BRM) physical and mental subscale scores.\n\nII. To compare longitudinal changes in global health status between treatment arms from randomization to 48 week (12 months) using the FACT-L TOI.\n\nPATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE:\n\nI. To compare participant-reported symptoms using selected PRO-CTCAE items between treatment arms such as rash, itching, skin dryness, numbness, and tingling.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and blood sample collection throughout the trial.\n\nARM II: Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.\n\nAfter completion of study treatment, patients are followed up annually until 10 years from randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)\n* Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \\[NCCN\\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.\n\n * Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease\n* Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review\n* Participants must have a PD-L1 status result (e.g. \\[\\< 1% versus \\>= 1% or unknown\\])\n* Participants must not have known EGFR mutations, or ALK gene fusion\n* Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines\n* Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization\n* Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy\n* Participants must not have received post-operative radiation therapy (PORT) for NSCLC\n* Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator\n* Participant must be ≥ 18 years old at time of study entry\n* Participants must have body weight \\> 30 kg\n* Participant must have Zubrod performance status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to randomization\n* Hemoglobin \\> 9.0 g/dL (within 28 days prior to randomization)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3/uL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3/uL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert\'s disease. Participants with history of Gilbert\'s disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)\n* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)\n* Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx\n* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants must not have had an organ transplant\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* Participants must not have received a live or live attenuated vaccine within 28 days prior randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations'}, 'identificationModule': {'nctId': 'NCT06498635', 'briefTitle': 'Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)', 'orgStudyIdInfo': {'id': 'NCI-2024-05588'}, 'secondaryIdInfos': [{'id': 'NCI-2024-05588', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'S2414', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'S2414', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180888', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180888', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (durvalumab)', 'description': 'Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and blood sample collection throughout the trial.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Biological: Durvalumab', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (active surveillance)', 'description': 'Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Other: Patient Observation', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm I (durvalumab)', 'Arm II (active surveillance)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Arm I (durvalumab)', 'Arm II (active surveillance)']}, {'name': 'Durvalumab', 'type': 'BIOLOGICAL', 'otherNames': ['Imfinzi', 'Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer', 'MEDI 4736', 'MEDI-4736', 'MEDI4736'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (durvalumab)']}, {'name': 'Patient Observation', 'type': 'OTHER', 'otherNames': ['Active Surveillance', 'deferred therapy', 'expectant management', 'Observation', 'Watchful Waiting'], 'description': 'Undergo active surveillance', 'armGroupLabels': ['Arm II (active surveillance)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (durvalumab)', 'Arm II (active surveillance)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Emily.Carvell@bmhcc.org', 'phone': '870-936-7066'}, {'name': 'Osarenren Ogbeide', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-741-8387'}, {'name': 'Steven B. Hardin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Veterans Affairs Loma Linda Healthcare System', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '310-423-8965'}, {'name': 'Karen L. Reckamp', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '916-734-3089'}, {'name': 'Surbhi Singhal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'courtney.steeneken@tmphysicians.com', 'phone': '310-750-3300'}, {'name': 'Karen L. Reckamp', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Torrance Memorial Physician Network - Cancer Care', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ccrp@co-cancerresearch.org', 'phone': '303-777-2663'}, {'name': 'Patrick W. Cobb', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Saint Mary's Hospital and Regional Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '860-545-5363'}, {'name': 'Krishna S. Gunturu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06451', 'city': 'Meriden', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '866-662-5678'}, {'name': 'Krishna S. Gunturu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Midstate Medical Center', 'geoPoint': {'lat': 41.53815, 'lon': -72.80704}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '860-224-5660'}, {'name': 'Krishna S. Gunturu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hospital of Central Connecticut', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '19967', 'city': 'Millville', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'research@beebehealthcare.org', 'phone': '302-291-6730'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beebe South Coastal Health Campus', 'geoPoint': {'lat': 38.54956, 'lon': -75.12324}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'lbarone@christianacare.org', 'phone': '302-623-4450'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'lbarone@christianacare.org', 'phone': '302-623-4450'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Oncology Hematology Consultants PA', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19971', 'city': 'Rehoboth Beach', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'research@beebehealthcare.org', 'phone': '302-291-6730'}, {'name': 'Gregory A. 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