Neoadjuvant Immunotherapy in Advanced NSCLC

Power Life Sciences

Status: Unknown

Conditions: Lung Cancer, Non-small Cell

Treatments: Biological: Immunotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT05137912

e4c2e8edac362acab7123654b9e734

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design