30 Participants Needed

SX-682 + Pembrolizumab for Lung Cancer

RW
Overseen ByRebecca Wood
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must stop taking systemic corticosteroids at least 7 days before starting the trial. If you are on small molecule inhibitor therapy, a washout period (time without taking the medication) of at least 5 half-lives is required before starting the study treatment.

Is the combination of SX-682 and Pembrolizumab safe for humans?

Pembrolizumab (also known as Keytruda) has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and more serious immune-related issues like pneumonitis (lung inflammation). While specific safety data for the combination with SX-682 is not provided, pembrolizumab's safety profile is well-documented in other conditions.12345

What makes the drug SX-682 + Pembrolizumab unique for lung cancer treatment?

The combination of SX-682 and Pembrolizumab is unique because it combines a new investigational drug, SX-682, with Pembrolizumab, a PD-1 inhibitor already approved for lung cancer, potentially enhancing the immune response against cancer cells.14567

What data supports the effectiveness of the drug pembrolizumab for lung cancer?

Pembrolizumab has been shown to improve survival in patients with non-small cell lung cancer (NSCLC), especially those whose tumors express a protein called PD-L1. It has been approved by the FDA for treating advanced stages of this cancer, demonstrating better outcomes compared to traditional chemotherapy.14589

Who Is on the Research Team?

CS

Christina S. Baik

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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.

Inclusion 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 willing to undergo a biopsy during treatment if my doctor says it's safe.
See 12 more

Exclusion Criteria

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.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive SX-682 orally twice daily and pembrolizumab intravenously every 3 weeks for up to 24 months

24 months
Bi-weekly visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

60 months
Periodic visits for imaging and blood sample collection

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • SX-682
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (SX-682, pembrolizumab)Experimental Treatment7 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Syntrix Biosystems, Inc.

Industry Sponsor

Trials
14
Recruited
810+

Published Research Related to This Trial

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
Pembrolizumab is a safe and effective immune checkpoint inhibitor that targets the PD-1 receptor, currently approved for treating advanced melanoma and metastatic non-small cell lung cancer (NSCLC).
Ongoing studies are exploring the potential of pembrolizumab in combination with other treatments for lung cancer and other cancer types, while also investigating biomarkers that may predict patient response to this therapy.
Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer.Dang, TO., Ogunniyi, A., Barbee, MS., et al.[2020]
Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.
In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Citations

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer. [2020]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Acute myelomonocytic leukemia during pembrolizumab treatment for non-small cell lung cancer: A case report. [2020]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Evaluation of pembrolizumab for the treatment of advanced non-small cell lung cancer: a retrospective, single-centre, single-arm study. [2022]
Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. [2022]
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