Neoadjuvant Immunotherapy in Advanced NSCLC

NCT ID: NCT05137912

Last Updated: 2022-02-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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

Conditions

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Lung Cancer, Non-small Cell

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

Patient Support

Role: CONTACT

Facility Contacts

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Michael B Gill

Role: primary

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.

Reference Type BACKGROUND
PMID: 33512555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32327180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34424417 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.withpower.com/terms-of-service

Participating Patient Terms of Service

Other Identifiers

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e4c2e8edac362acab7123654b9e734

Identifier Type: -

Identifier Source: org_study_id

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