Neoadjuvant Immunotherapy in Advanced NSCLC
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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 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 https://www.withpower.com/trial/pha se-4-2019-e67c1. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.
Study Design
Outcome Measures
Primary Outcome Measures
- Major Pathological Response [12 Weeks]
To evaluate the major pathological response (MPR) rate of participants
Secondary Outcome Measures
- Objective Response Rate [12 Weeks]
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
- MPR based on diverse PD-L1 expression [12 Weeks]
Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants
- Progression Free Survival [12 Weeks]
Progression Free Survival (PFS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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= 18 Years of Age
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Informed consent is provided
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Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
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Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative
Exclusion Criteria:
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EGFR mutation positive and ALK translocation positive
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Active central nervous system (CNS) metastases
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Autoimmune diseases
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Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
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Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4
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Women who are breast feeding or pregnant
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Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Power Life Sciences | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, [Power Life Sciences Inc.](www.withpower.com)
Study Documents (Full-Text)
More Information
Additional Information:
- Participating Patient Terms of Service
- Immunotherapy As Neoadjuvant Therapy For Non Small Cell Lung Cancer
- Patient Support Line
Publications
- 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. Review.
- Gutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-CarpeƱo 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. Review.
- 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.
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