SX-682 + Atezolizumab for Non-Small Cell Lung Cancer

RW
Overseen ByRebecca Wood
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Washington
Must be taking: Anti-PD-1, Anti-PD-L1, Platinum chemotherapy
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 trial explores a new treatment combination for individuals with advanced or recurring non-small cell lung cancer (NSCLC) that has spread. The treatment combines SX-682, an experimental therapy that may help the immune system attack cancer cells, with atezolizumab, an immunotherapy that boosts the body's defenses against cancer. This trial may suit those previously treated for NSCLC whose cancer has returned or progressed. Participants must have tried specific therapies and have cancer that is not responding to those treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 5 half-lives from your last dose of any recent systemic therapy before starting the study treatment. If you're on corticosteroids, they must be tapered off 7 days before the first dose of SX-682.

Is there any evidence suggesting that SX-682 and atezolizumab are likely to be safe for humans?

Research shows that combining atezolizumab with other treatments can cause immune-related side effects in some patients. About 27.7% of patients may experience these side effects, with severe reactions in 9.9% and very severe reactions in 2.1%.

Studies have found atezolizumab to be generally safe for people with non-small cell lung cancer, even for those whose cancer has spread to the brain. This indicates it is usually well-tolerated, though side effects can still occur.

SX-682 is an experimental treatment designed to help the immune system fight cancer cells. Since researchers are testing SX-682 with atezolizumab, there is less information about its safety on its own. However, because the trial is in Phase 2, early tests have shown it is safe enough to continue testing in humans.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about SX-682 combined with atezolizumab for non-small cell lung cancer because it offers a novel approach to treatment. Unlike typical therapies that often focus solely on the immune system's checkpoints, SX-682 targets the CXCR1/2 chemokine receptors, which are involved in tumor growth and metastasis. This unique mechanism could potentially enhance the effectiveness of atezolizumab, an immune checkpoint inhibitor, by not only boosting the immune response but also directly impeding cancer cell communication. This dual-action strategy might offer improved outcomes compared to existing treatments that primarily rely on checkpoint inhibition alone.

What evidence suggests that SX-682 and atezolizumab might be effective for non-small cell lung cancer?

Research shows that SX-682 blocks proteins that help the immune system attack and destroy cancer cells. Atezolizumab, an immunotherapy treatment, also aids the immune system in fighting cancer. Studies have found that combining atezolizumab with other treatments can improve outcomes for people with non-small cell lung cancer (NSCLC). In this trial, participants will receive a combination of SX-682 and atezolizumab to enhance the body's natural defenses against cancer. Although specific data on the effectiveness of SX-682 and atezolizumab together for NSCLC is not yet available, their mechanisms suggest a promising approach for treating advanced or recurrent cases.12678

Who Is on the Research Team?

CB

Christina Baik, MD, MPH

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic, recurrent non-small cell lung cancer (NSCLC). Participants should have a form of NSCLC that has spread and returned after improvement. Key eligibility details are not provided; typically, participants must meet certain health standards and may need to provide biopsy samples.

Inclusion Criteria

For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
Negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to initiation of study treatment for participants of childbearing potential
Ability to understand and willingness to sign a written informed consent document
See 17 more

Exclusion Criteria

Known history of primary immunodeficiency
Any serious or uncontrolled concomitant disorder that 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
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive SX-682 orally twice daily and atezolizumab subcutaneously on day 1 of each cycle. Cycles repeat every 21 days for up to 5 years.

Up to 5 years
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 12 weeks for up to 84 months.

84 months
Every 12 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • SX-682

Trial Overview

The trial is testing the effectiveness of SX-682 in combination with atezolizumab, an immunotherapy drug. SX-682 aims to stimulate the immune system to attack tumor cells while atezolizumab may prevent tumor growth and spread. The study includes biospecimen collection and imaging tests like CT scans and MRIs.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (SX-682 and atezolizumab)Experimental Treatment6 Interventions

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+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Syntrix Biosystems, Inc.

Industry Sponsor

Trials
14
Recruited
810+

Citations

SX-682 and Atezolizumab for the Treatment of Advanced ...

This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have ...

SX-682 + Atezolizumab for Non-Small Cell Lung Cancer

The trial is testing the effectiveness of SX-682 in combination with atezolizumab, an immunotherapy drug. SX-682 aims to stimulate the immune system to attack ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39758245/

Outcomes of Combined Atezolizumab Plus Chemotherapy ...

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Results of the IFCT-1905 CLINATEZO real-world study.

Long-term effectiveness and treatment sequences in patients with extensive stage small cell lung cancer receiving atezolizumab plus chemotherapy: Results of the ...

Outcomes of Combined Atezolizumab Plus Chemotherapy in ...

Immune-related adverse events were observed in 27.7% of patients, with grade 3 or higher in 9.9% of patients, and grade 5 in 2.1% of patients.

Adaptive therapy for perioperative non–small cell lung cancer

Data from the LACE meta-analysis indicated that over 30 % of patients with locally advanced NSCLC developed distant metastases following curative surgery [30].

Atezolizumab Combo Demonstrates Favorable Efficacy ...

Patients with non-small cell lung cancer with brain metastases experienced a favorable safety profile along with efficacy results when treated ...