Neoadjuvant Immunotherapy in Advanced NSCLC

• Conditions: Lung Cancer, Non-small Cell

• Registration Number: NCT05137912
• Lead Sponsor: Power Life Sciences Inc.

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.

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 \<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.

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Study Start: 2022-02-01
• Last Update Posted: 2022-02-07
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Pathological Response	12 Weeks	To evaluate the major pathological response (MPR) rate of participants

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	12 Weeks	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Progression Free Survival	12 Weeks	Progression Free Survival (PFS)
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

Trial Locations

Locations (1)

Power Life Sciences; 🇺🇸 San Francisco, California, United States