Neoadjuvant Immunotherapy in Advanced NSCLC

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05137912
Collaborator
(none)
10
1
10
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Immunotherapy

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 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Neoadjuvant Immunotherapy in Advanced NSCLC
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Major Pathological Response [12 Weeks]

    To evaluate the major pathological response (MPR) rate of participants

Secondary Outcome Measures

  1. Objective Response Rate [12 Weeks]

    Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)

  2. MPR based on diverse PD-L1 expression [12 Weeks]

    Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants

  3. Progression Free Survival [12 Weeks]

    Progression Free Survival (PFS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Power Life Sciences San Francisco California United States 94107

Sponsors and Collaborators

  • Power Life Sciences Inc.

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Power Life Sciences Inc.
ClinicalTrials.gov Identifier:
NCT05137912
Other Study ID Numbers:
  • e4c2e8edac362acab7123654b9e734
First Posted:
Nov 30, 2021
Last Update Posted:
Feb 7, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022