Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 4:22 AM
Study NCT ID:
NCT05137912
Status:
UNKNOWN
Last Update Posted:
2022-02-07
First Post:
2021-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Immunotherapy in Advanced NSCLC
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': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-07', 'size': 53707, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-21T11:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-21', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Pathological Response', 'timeFrame': '12 Weeks', 'description': 'To evaluate the major pathological response (MPR) rate of participants'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '12 Weeks', 'description': 'Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)'}, {'measure': 'MPR based on diverse PD-L1 expression', 'timeFrame': '12 Weeks', 'description': 'Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants'}, {'measure': 'Progression Free Survival', 'timeFrame': '12 Weeks', 'description': 'Progression Free Survival (PFS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer, Non-small Cell']}, 'referencesModule': {'references': [{'pmid': '33512555', 'type': 'BACKGROUND', 'citation': 'Jiang L, Huang J, Jiang S, Rong W, Shen Y, Li C, Tian Y, Ning J, Chen X, Yang Y, Ding Z, Li Z, Luo Q. The surgical perspective in neoadjuvant immunotherapy for resectable non-small cell lung cancer. Cancer Immunol Immunother. 2021 Aug;70(8):2313-2321. doi: 10.1007/s00262-021-02847-1. Epub 2021 Jan 29.'}, {'pmid': '32327180', 'type': 'BACKGROUND', 'citation': 'Broderick SR. Adjuvant and Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer. Thorac Surg Clin. 2020 May;30(2):215-220. doi: 10.1016/j.thorsurg.2020.01.001.'}, {'pmid': '34424417', 'type': 'BACKGROUND', 'citation': 'Gutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-Carpeno J. Neoadjuvant Chemoimmunotherapy in Patients with Resectable Non-small Cell Lung Cancer. Curr Treat Options Oncol. 2021 Aug 23;22(10):91. doi: 10.1007/s11864-021-00885-6.'}], 'seeAlsoLinks': [{'url': 'https://www.withpower.com/terms-of-service', 'label': 'Participating Patient Terms of Service'}, {'url': 'https://www.withpower.com/contact-us', 'label': 'Patient Support Line'}]}, 'descriptionModule': {'briefSummary': "A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. One such example would be to evaluate either single agent or an immunotherapy combination with chemotherapy. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.", 'detailedDescription': 'A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. \\[The Power Life Sciences Investigative Team\\](https://www.withpower.com) is running a study to evaluate either single agent or an immunotherapy combination with chemotherapy. Patients can contact a site administrator via the information below, or enroll directly via \\<a href="https://www.withpower.com/trial/phase-4-2019-e67c1"\\>https://www.withpower.com/trial/phase-4-2019-e67c1\\</a\\>. Following this, analysis of biomarkers will be conducted to provide personalization in one\'s regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stage IIA-IIIA NSCLC', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 Years of Age\n* Informed consent is provided\n* Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative\n\nExclusion Criteria:\n\n* EGFR mutation positive and ALK translocation positive\n* Active central nervous system (CNS) metastases\n* Autoimmune diseases\n* Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4\n* Women who are breast feeding or pregnant\n* Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study'}, 'identificationModule': {'nctId': 'NCT05137912', 'briefTitle': 'Neoadjuvant Immunotherapy in Advanced NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Neoadjuvant Immunotherapy in Advanced NSCLC', 'orgStudyIdInfo': {'id': 'e4c2e8edac362acab7123654b9e734'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immunotherapy', 'type': 'BIOLOGICAL', 'description': 'Patients within this intervention group will be histologically confirmed to have resectable non small cell lung cancer with stage II-IIIA.\n\nPatients may receive single agent immunotherapy or immunotherapy combined with chemotherapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '(415) 900-4227'}, {'name': 'Patient Support', 'role': 'CONTACT', 'email': 'hello@withpower.com'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': '[Power Life Sciences Inc.](www.withpower.com)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}