A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy
University of Washington
Summary
This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.
Description
OUTLINE: Patients receive SX-682 orally (PO) twice daily (BID) on days -7 - 21 of cycle 1 and on days 1-21 of each cycle thereafter and atezolizumab subcutaneously (SC) on day 1 of each cycle. Cycles repeat every 21 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo brain magnetic resonance imaging (MRI) during screening and computed tomography (CT) scan or MRI, blood sample collection and tumor biopsy on trial and may undergo at screening. After completion of study treatment, patients are followed up within 30 days if treatment is discont…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years and older * Ability to understand and willingness to sign a written informed consent document * Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK fusion, ROS1 fusion or RET fusions. * For participants with NSCLC harboring an oncogenic alteration other than the above must have received prior targeted therapy (e.g. small molecule inhibitor therapy or antibody drug conjugates). A wash-out of at least 5 half-lives is required prior to start of study treatment * Metastatic or recurrent NSCLC. Stage…
Interventions
- BiologicalAtezolizumab
Given SC
- DrugCXCR1/2 Inhibitor SX-682
Given PO
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureBiopsy Procedure
Undergo tumor biopsy
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington