Trial Title:
SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer
NCT ID:
NCT05570825
Condition:
Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT or CT
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
CXCR1/2 Inhibitor SX-682
Description:
Given PO
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
SX 682
Other name:
SX-682
Other name:
SX682
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Given IV
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
Keytruda
Other name:
Lambrolizumab
Other name:
MK-3475
Other name:
SCH 900475
Other name:
BCD-201
Other name:
Pembrolizumab Biosimilar BCD-201
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (SX-682, pembrolizumab)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
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.
Detailed description:
OUTLINE:
Patients receive SX-682 orally (PO) twice daily (BID), starting 7 days prior to the start
of pembrolizumab, and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles
repeat every 3 weeks for up to 24 months in the absence of disease progression or
unacceptable toxicity. 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.
After completion of study treatment, patients are followed up for up to 60 months.
Criteria for eligibility:
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 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
- 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 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
- 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 1 year prior to consenting (i.e., disease modifying
agents, corticosteroids). Replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is allowed
- Inability to discontinue systemic corticosteroid therapy; systemic steroids must be
tapered off 7 days prior to first dose of SX-682
- 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 3 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Wood
Phone:
206-606-6970
Email:
rwood1@fredhutch.org
Investigator:
Last name:
Christina S. Baik
Email:
Principal Investigator
Start date:
April 6, 2023
Completion date:
July 1, 2028
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Syntrix Biosystems, Inc.
Agency class:
Industry
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570825
