Lung Cancer, Non-small Cell
Conditions
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.
Interventions
BIOLOGICALImmunotherapy
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.
Sponsors
Power Life Sciences Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response | 12 Weeks | To evaluate the major pathological response (MPR) rate of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 12 Weeks | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) |
| 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 |
| Progression Free Survival | 12 Weeks | Progression Free Survival (PFS) |
Countries
United States
Contacts
Primary ContactMichael B Gill
Backup ContactPatient Support
Outcome results
None listed