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NCT05137912 | Unknown status | Lung Cancer, Non-small Cell

Neoadjuvant Immunotherapy in Advanced NSCLC
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.

Condition or disease

Lung Cancer, Non-small Cell

Intervention/treatment

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](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. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.}}

Study Type : Observational
Estimated Enrollment : 10 participants
Official Title : Neoadjuvant Immunotherapy in Advanced NSCLC
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Criteria
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
Neoadjuvant Immunotherapy in Advanced NSCLC

Location Details

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Neoadjuvant Immunotherapy in Advanced NSCLC

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Power Life Sciences

San Francisco, California, United States, 94107