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PD-1 Inhibitor
SX-682 + Pembrolizumab for Lung Cancer
Phase 2
Recruiting
Led By Christina S. Baik
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically or cytologically confirmed non-small cell lung cancer with no known oncogenic EGFR mutation, ALK rearrangement, ROS1 rearrangement or RET fusions
Negative beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential. Pregnant or breast feeding women are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing whether a combination of two drugs, SX-682 and pembrolizumab, is more effective than either drug alone in treating patients with metastatic or recurrent non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IIIC or IV non-small cell lung cancer that's spread or come back, without certain genetic mutations. Participants need a specific blood platelet count, no recent serious infections, and must not have had prior treatments like chemotherapy for their metastatic disease. They should be in good physical condition (ECOG status 0 or 1), able to provide tissue samples, and use contraception if applicable.Check my eligibility
What is being tested?
The trial tests SX-682 combined with pembrolizumab against advanced non-small cell lung cancer. SX-682 blocks signals that help tumors evade the immune system while pembrolizumab activates T-cells to attack cancer cells. The study aims to see if this combo is more effective than individual treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation of organs (like lungs causing breathing issues), hormonal changes affecting thyroid function, and possible infusion-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer does not have EGFR, ALK, ROS1, or RET mutations.
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I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.
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My tumor shows PD-L1 expression of 1% or more.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best objective response rate
Secondary outcome measures
Disease control rate
Duration of response
Frequency and severity of adverse events
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SX-682, pembrolizumab)Experimental Treatment7 Interventions
Patients receive SX-682 PO BID, starting 7 days prior to the start of pembrolizumab, and pembrolizumab 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 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,743 Previous Clinical Trials
1,847,840 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,554 Total Patients Enrolled
Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
777 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer has spread or come back and cannot be cured by surgery or radiation.I agree to use birth control during and for three months after treatment.I am 18 years old or older.I am willing to undergo a biopsy during treatment if my doctor says it's safe.I am willing to provide a previous biopsy sample or undergo a new biopsy.You have enough infection-fighting white blood cells in your body.My lung cancer does not have EGFR, ALK, ROS1, or RET mutations.I have at least one tumor that can be measured.You have enough platelets in your blood.I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.Your AST and ALT levels are not more than 2.5 times the upper limit of normal.I have brain metastases but no symptoms, and I haven't taken steroids or antiepileptics in the last 7 days.I do not have active hepatitis B, C, or tuberculosis, and haven't needed IV antibiotics in the last week.I have received treatments like chemotherapy or immunotherapy for my cancer after it spread or came back.I haven't had any active cancers in the last 2 years, except for early-stage or skin cancer.I do not have any serious health issues that would stop me from completing the study.I have had an organ transplant and take drugs to suppress my immune system.I haven't taken immune-modifying treatments for an autoimmune disease in the last year.I have not had radiotherapy in the week before starting the study treatment.I've had treatment for spinal cord compression and haven't needed steroids for over a week.I have lung inflammation now or had it before due to cancer treatment.You have a history of a weakened immune system from birth.Your creatinine levels are below 2.0 mg/dL.I can stop taking steroids 7 days before starting SX-682 treatment.I cannot stop taking steroids for my severe lung disease 7 days before starting the study treatment.I have HIV that is not currently under control.I haven't had major surgery in the last 3 weeks or minor surgery in the last 2 weeks.I had lung inflammation treated with steroids in the last 6 months.My tumor shows PD-L1 expression of 1% or more.My heart's electrical activity shows prolonged QT intervals.Your hemoglobin level is at least 8 grams per deciliter.I am fully active or restricted in physically strenuous activity but can do light work.I do not have serious heart or brain blood vessel problems.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SX-682, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the patient quota for this clinical investigation?
"Affirmative. Clinicaltrials.gov indicates that this trial, which was initially announced on December 9th 2022, is currently in search of patients to participate. 30 participants are required and the research will only be conducted at one centre."
Answered by AI
Are there any vacancies for participants in this experiment?
"Affirmative. The information on clinicaltrials.gov attests that this medical research is enrolling participants, and was made available to the public on December 9th 2022 before being revised most recently on November 9th 2022. 30 patients are sought from 1 separate location for inclusion in the trial."
Answered by AI
What potential risks do patients face when taking Treatment (SX-682, pembrolizumab)?
"Although SX-682, pembrolizumab is in a Phase 2 trial and has no efficacy data yet, we assign it a safety rating of 2 due to the available information."
Answered by AI
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