Neoadjuvant Immunotherapy in Advanced NSCLC

January 21, 2022 updated by: Power Life Sciences Inc.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Stage IIA-IIIA NSCLC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Pathological Response
Time Frame: 12 Weeks
To evaluate the major pathological response (MPR) rate of participants
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 12 Weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
12 Weeks
MPR based on diverse PD-L1 expression
Time Frame: 12 Weeks
Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants
12 Weeks
Progression Free Survival
Time Frame: 12 Weeks
Progression Free Survival (PFS)
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Power Life Sciences Inc.

Investigators

  • Study Director: Michael B Gill, [Power Life Sciences Inc.](www.withpower.com)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • e4c2e8edac362acab7123654b9e734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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