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NCT05137912 Clinical Trial

Neoadjuvant Immunotherapy in Advanced NSCLC

Lung Cancer, Non-small Cell Clinical Trial

Official title:
Neoadjuvant Immunotherapy in Advanced NSCLC

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05137912
Other study ID # e4c2e8edac362acab7123654b9e734
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date December 1, 2022

Study information
Verified date January 2022
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone (415) 900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date December 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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.

Locations
Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Gutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-Carpeño 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Major Pathological Response To evaluate the major pathological response (MPR) rate of participants 12 Weeks
Secondary Objective Response Rate Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 12 Weeks
Secondary 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 12 Weeks
Secondary Progression Free Survival Progression Free Survival (PFS) 12 Weeks
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