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SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05570825
Recruitment Status : Recruiting
First Posted : October 7, 2022
Last Update Posted : April 25, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Syntrix Biosystems, Inc.
Information provided by (Responsible Party):
University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Procedure: Biopsy Procedure: Biospecimen Collection Procedure: Computed Tomography Drug: CXCR1/2 Inhibitor SX-682 Procedure: Magnetic Resonance Imaging Biological: Pembrolizumab Procedure: Positron Emission Tomography Phase 2

Detailed Description:

OUTLINE:

Patients receive SX-682 orally (PO) and pembrolizumab intravenously (IV) on study. Patients also undergo biopsy and positron emission tomography (PET)/computed tomography (CT) or CT at screening and on study and undergo magnetic resonance imaging (MRI) and collection of blood samples at screening, throughout the study, and during follow up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of SX-682 and Pembrolizumab in Patients With Treatment Naive Stage IV or Recurrent Non-Small Cell Lung Cancer
Actual Study Start Date : April 6, 2023
Estimated Primary Completion Date : July 1, 2027
Estimated Study Completion Date : July 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Treatment (SX-682, pembrolizumab)
Patients receive SX-682 PO and pembrolizumab IV on study. Patients also undergo biopsy and PET/CT or CT at screening and on study and undergo MRI and collection of blood samples at screening, throughout the study, and during follow up.
Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Computed Tomography
Undergo PET/CT or CT
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: CXCR1/2 Inhibitor SX-682
Given PO
Other Names:
  • SX 682
  • SX-682
  • SX682

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Best objective response rate [ Time Frame: Up to 6 years ]

    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).



Secondary Outcome Measures :
  1. Response rate within cohorts [ Time Frame: Up to 6 years ]
    Evaluated within the cohorts separately (>= 50% and 1-49% PD-L1 tumor proportion score). Will evaluate the response rate within the cohorts separately. Within each cohort, the response rates and associated 80% confidence intervals will be estimated.

  2. Disease control rate [ Time Frame: Up to 6 years ]
  3. Duration of response [ Time Frame: Date of first documentation of confirmed response (CR or PR) to date of first documentation of progression, assessed up to 6 years ]
    Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method.

  4. Progression-free survival [ Time Frame: Date of study registration to date of first documentation of progression, assessed up to 6 years ]
    Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method.

  5. Overall survival [ Time Frame: Date of study registration to date of death due to any cause, assessed up to 6 years ]
    Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method.

  6. Frequency and severity of adverse events [ Time Frame: Up to 6 years ]
    Toxicity frequencies will be estimated with 95% confidence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 fusions
  • 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
  • At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Subjects must have ECOG PS 0 or 1 at the time of informed consent and at the time of treatment initiation
  • Must be willing to provide pre-treatment archived specimen or undergo a biopsy procedure if archived specimen is not available
  • Must be willing to provide an on-treatment biopsy, if deemed safe by the treating physician
  • Platelet count >= 100,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Hemoglobin >= 8g/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
  • Creatinine =< 2.0 mg/dL
  • Women of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal or barrier method) prior to treatment initiation, during treatment and for three months after completing treatment
  • Negative beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential. Pregnant or breast feeding women are not eligible
  • Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  • Prior chemotherapy or immune checkpoint inhibitor or immune-modulatory therapy (e.g. anti-PD[L]1, anti-CTLA4, anti-TIM3, anti-GITR, anti-TIGIT, anti-LAG3), for metastatic or recurrent disease

    • Prior chemotherapy and immune checkpoint inhibitor and immune modulatory therapy in the curative setting is allowed as long as treatment was completed > 6 months 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 stage I 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 antiepileptics within 7 days prior to start of study treatment

    • Patients with untreated CNS metastases may be enrolled as long as they meet the above criteria. Patients 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
  • Participants must not have an active autoimmune disease that has required immune modulating treatment within two years prior to consenting (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
  • Known history of primary immunodeficiency
  • History of organ transplant that requires use of immunosuppressives
  • Current symptomatic pneumonitis and any past history of immune checkpoint inhibitor related pneumonitis regardless of steroid treatment history
  • History of non-infectious pneumonitis (e.g. radiation pneumonitis) that required steroids within 6 months of start of study treatment
  • Radiotherapy within 7 days of start of study treatment
  • Major surgery within 21 days of start of study treatment. Minor surgery within 2 weeks of start of study treatment. Placement of vascular access device and biopsies are not considered major or minor surgery and are allowed
  • Electrocardiogram (EKG) demonstrating a corrected QT (QTc) interval > 480 msec on three consecutive EKGs or patients with congenital long QT syndrome
  • Severe lung disease (e.g. chronic obstructive pulmonary disease [COPD]) who cannot stop steroids 7 days prior to start of study treatment
  • Serious cerebrovascular and cardiac disease defined as:

    • Active unstable angina pectoris
    • Congestive heart failure NYHA (New York Heart Association) > grade 3
    • Acute myocardial infarction within 3 months of consenting
    • Stroke or transient ischemic attack within 3 months of consenting
  • Known active chronic infections: Active hepatitis B, hepatitis C and tuberculosis. Testing is not required for assessment of eligibility. Active infection requiring IV antibiotics within 7 days of study treatment initiation

    • Hepatitis C virus (HCV) infection: Patients with known history of HCV infection are eligible if HCV viral load is below the limit of quantification per local assay
    • Hepatitis B virus (HBV) infection: Patients with known history of HBV infection are eligible if HBV viral load is below the limit of quantification and negative hepatitis B virus surface antigen (HBsAg) per local assay
  • Known uncontrolled HIV (human immunodeficiency virus) infection

    • Participants with known HIV infection are allowed if they are receiving anti-retroviral therapy, have CD4+ T-cell count >= 350 cells/uL within 6 months prior to study treatment initiation and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection
  • Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05570825


Contacts
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Contact: Rebecca Wood 206-606-6970 rwood1@seattlecca.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Rebecca Wood    206-606-6970    rwood1@seattlecca.org   
Principal Investigator: Christina S. Baik         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Syntrix Biosystems, Inc.
Investigators
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Principal Investigator: Christina S. Baik Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT05570825    
Other Study ID Numbers: RG1122737
NCI-2022-07428 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P50CA228944 ( U.S. NIH Grant/Contract )
11019 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: October 7, 2022    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action