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.
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
Presence of other active cancers within the last 2 years. Participants with another cancer who have received definitive therapy at least 2 years previously and no evidence of recurrence are eligible. All participants with previously treated in situ carcinoma are eligible, as are participants with history of non-melanoma skin cancer
Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no ongoing requirement for steroids within 7 days prior to start of study treatment, no history of intracranial hemorrhage or spinal cord hemorrhage. If the patient is receiving anti-convulsant therapy, the dose is considered stable
Participants with untreated CNS metastases may be enrolled as long as they meet the above criteria. Participants with bulky CNS metastases should consider receiving radiation prior to study entry per investigator judgment
Participants with spinal cord compression must have received local treatment and must have been symptomatically stable with no use of steroids for at least 7 days prior to start of study treatment
Single group
Atezolizumab
Biological/VaccineGiven SC
CXCR1/2 Inhibitor SX-682
DrugGiven PO
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Biopsy Procedure
Procedure/SurgeryUndergo tumor biopsy
Objective response rate
Response by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST).
Response rate in the subset of participants with circulating IL-8 levels greater than or equal to 23 pg/ml
Response by iRECIST. Will be summarized along with 80% confidence intervals.
Duration of response
Will be estimated using the method of Kaplan-Meier.
Disease control rate
Defined as immune mediated complete response, immune mediated partial response, confirmed and unconfirmed, immune mediated stable disease.
Response by Response Evaluation Criteria in Solid Tumors version 1.1
Defined as complete response and partial response (confirmed and unconfirmed), stable disease.
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University of Washington
Lead sponsor
Genentech, Inc.
Collaborator
Syntrix Biosystems, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator
