This phase II trial tests whether CXCR1/2 inhibitor SX-682 (SX-682) with pembrolizumab works to treat patients with stage IIIC or IV non-small cell lung cancer that has spread to other parts of the body (metastatic) or that has come back (recurrent). SX-682 is a drug that binds to receptors on some types of immune and cancer cells, inhibiting signaling pathways, reducing inflammation, and allowing other types of immune cells to kill and eliminate cancer cells. Pembrolizumab is a monoclonal antibody that binds to a receptor called PD-1 that is found on the surface of T-cells (a type of immune cell), activating an immune response against tumor cells. Giving SX-682 in combination with pembrolizumab may be more effective at treating patients with metastatic or recurrent non-small cell lung cancer than giving these treatments alone.
Subjects aged 18 years and older
Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK rearrangement, ROS1 rearrangement or RET rearrangement
Tumoral PD-L1 expression >=1% by any Clinical Laboratory Improvement Act (CLIA)-certified assay
Metastatic or recurrent non-small cell lung cancer (NSCLC). Stage IIIC per 8th edition TNM stage classification is allowed if not amenable to curative surgery or radiation per investigator judgment
Participants may have received prior chemotherapy, immune checkpoint inhibitor, and/or immune modulatory therapy in the curative setting if the last dose of treatment was more than (>) 24 weeks prior to consenting
For patients with NSCLC harboring an oncogenic alteration other than listed may have received prior small molecule inhibitor therapy (e.g. MET inhibitor for MET exon 14 mutated NSCLC). A wash-out period of at least 5 half-lives is required prior to start of study treatment
Presence of other active cancers within the last 2 years. Patients with any prior early stage cancer who have received definitive local treatment at least 2 years previously and no evidence of recurrence are eligible. All patients with previously treated in situ carcinoma are eligible, as patients with history of non-melanoma skin cancer
Symptomatic central nervous system (CNS) metastases; participants with known brain metastasis must be asymptomatic with no steroids or escalating doses of antiepileptics within 7 days prior to start of study treatment
Single group
Biopsy
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Computed Tomography
Procedure/SurgeryUndergo PET/CT or CT
CXCR1/2 Inhibitor SX-682
DrugGiven PO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Pembrolizumab
Biological/VaccineGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Best objective response rate
Response is defined as a complete response (CR) or partial response (PR) as best objective response. For the primary analyses, binary proportions will be estimated along with 90% confidence intervals (consistent with 1-sided 5% level testing).
Response rate within subgroups
Will be defined by low and high tumor proportion score (TPS) separately (if there are sufficient numbers of low TPS, will evaluate the high TPS group). The response rates and associated 80% confidence intervals will be estimated.
Disease control rate
Will be defined as CR, PR, or stable disease.
Duration of response
Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method.
Progression-free survival
Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method.
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Syntrix Biosystems, Inc.
Collaborator
