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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response | To evaluate the major pathological response (MPR) rate of participants | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) | 12 Weeks |
| MPR based on diverse PD-L1 expression | Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants |
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Inclusion Criteria:
Exclusion Criteria:
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Stage IIA-IIIA NSCLC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Gill | Contact | (415) 900-4227 | bask@withpower.com | |
| Patient Support | Contact | hello@withpower.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Gill | [Power Life Sciences Inc.](www.withpower.com) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Power Life Sciences | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512555 | Background | 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. | |
| 32327180 | Background |
| Label | URL |
|---|---|
| Participating Patient Terms of Service | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2021 | Jan 21, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 12 Weeks |
| Progression Free Survival | Progression Free Survival (PFS) | 12 Weeks |
| 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. |
| 34424417 | Background | 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. |
| Immunotherapy As Neoadjuvant Therapy For Non Small Cell Lung Cancer | View source |
| Patient Support Line | View source |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |