Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10 participants
OBSERVATIONAL
2022-02-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Immunotherapy
Patients within this intervention group will be histologically confirmed to have resectable non small cell lung cancer with stage II-IIIA.
Patients may receive single agent immunotherapy or immunotherapy combined with chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Informed consent is provided
* Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative
Exclusion Criteria
* Active central nervous system (CNS) metastases
* Autoimmune diseases
* Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4
* Women who are breast feeding or pregnant
* Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study
18 Years
ALL
No
Sponsors
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Power Life Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael B Gill
Role: STUDY_DIRECTOR
[Power Life Sciences Inc.](www.withpower.com)
Locations
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Power Life Sciences
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Participating Patient Terms of Service
Patient Support Line
Other Identifiers
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e4c2e8edac362acab7123654b9e734
Identifier Type: -
Identifier Source: org_study_id
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