Cancer-Lung-Non small Cell
| Title: | An Open-Label, Non-randomized, Prospective Biomarker Study to Assess Analytic Concordance Between Non-invasive Testing and Tissue Testing for EGFR T790M Mutation Detection in Patients With Non-small Cell Lung Cancer |
| Description: | The study is being done to determine if non-invasive testing (urine and plasma testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status. EGFR is a type of protein found on the surface of cells in the body. When this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a mutation that develops in response to cancer treatment of the EGFR mutation |
| Drug/Procedure: | |
| NCT Number: | 03137264 |
| Notes: | |
| Start Date: | 9/25/17 |
| Status: | Recruiting |
| Principal Name: | Scott Pierson, MD |
| Contact Name: | Tina Schied, CCRC |
| Phone: | (208)367-3481 |
| Title: | A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (POZITIVE20-1) |
| Description: | This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in up to 174 patients with NSCLC exon 20 insertion mutations (87 patients with EGFR exon 20 insertion mutations and 87 patients with HER2 exon 20 insertion mutations). |
| Drug/Procedure: | Poziotinib |
| NCT Number: | 03318939 |
| Notes: | Phase 2 |
| Start Date: | 3/30/18 |
| Status: | Recruiting |
| Principal Name: | Karl Schultheiss, MD |
| Contact Name: | Tina Schied, CCRC |
| Phone: | (208)367-3481 |
| Title: | XALT3 Study X396-CLI-301: Phase 3 Randomized Study Comparing X-396 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients |
| Description: | This study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI), to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving X-396 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified. |
| Drug/Procedure: | X-396 (ensartinib); crizotinib |
| NCT Number: | 02767804 |
| Notes: | Phase 3 |
| Start Date: | 4/24/17 |
| Status: | Recruiting |
| Principal Name: | Kerry Pulver, MD |
| Contact Name: | Tina Schied, CCRC |
| Phone: | (208)367-3481 |