Clinical trial NCT05137912: Neoadjuvant Immunotherapy in Advanced NSCLC
Official title: Neoadjuvant Immunotherapy in Advanced NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer, Non-small Cell
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage IIA-IIIA NSCLC

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.

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. \[The Power Life Sciences Investigative Team\](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.

Eligibility criteria: Inclusion Criteria:

* \>= 18 Years of Age
* 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:

* EGFR mutation positive and ALK translocation positive
* 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

Primary outcomes:
measure: Major Pathological Response
timeFrame: 12 Weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 12 Weeks
measure: MPR based on diverse PD-L1 expression
timeFrame: 12 Weeks
measure: Progression Free Survival
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: [Power Life Sciences Inc.](www.withpower.com)
name: Michael B Gill
role: STUDY_DIRECTOR
References:
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.
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.
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.