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UnknownNot applicableNCT05137912
Official study title

Neoadjuvant Immunotherapy in Advanced NSCLC

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedImmunotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 7, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Power Life Sciences Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Power Life Sciences Inc.
Interventions being studied
Biological: Immunotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Chemotherapy→
Study topics
Before surgery (neoadjuvant)→After surgery (adjuvant)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Power Life SciencesSan Francisco, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2022. Always confirm current availability with the study team.

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