NCT05137912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

November 16, 2021

Last Update Submit

January 21, 2022

Conditions

Lung Cancer, Non-small Cell

Outcome Measures

Primary Outcomes (1)

  • Major Pathological Response

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

    12 Weeks

Secondary Outcomes (3)

  • Objective Response Rate

    12 Weeks

  • MPR based on diverse PD-L1 expression

    12 Weeks

  • Progression Free Survival

    12 Weeks

Interventions

ImmunotherapyBIOLOGICAL

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stage IIA-IIIA NSCLC

You may qualify if:

  • \>= 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

  • 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.

    PMID: 33512555BACKGROUND

  • 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.

    PMID: 32327180BACKGROUND

  • 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.

    PMID: 34424417BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Michael B Gill

    [Power Life Sciences Inc.](www.withpower.com)

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227bask@withpower.com

Patient Support

CONTACT

hello@withpower.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 30, 2021

Study Start

February 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

February 7, 2022

Record last verified: 2022-01

Locations

US(1)