GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC

Overview

About this study

The purpose of this study is to evaluate whether CAN-2409 + prodrug added to standard of care immune checkpoint inhibitor (ICI) therapy will be safe and improve the outcome for Non-small Cell Lung Cancer (NSCLC) patients that have stable disease or readiographic progression after at least 18 weeks of ICI therapy or that have refractory disease after at least 9 weeks of ICI therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients with Stage III/IV NSCLC on treatment with anti-PD-1/PD-L1 (ICI) +/- chemotherapy and:
    • have persistent but stable disease at least 18 weeks after starting ICI treatment, b) have radiographic progressive disease at least 18 weeks after starting ICI treatment;
    • have radiographic progressive disease at least 18 weeks after starting ICI treatment; or
    • have refractory disease defined as progressed by imaging at least 9 weeks after starting ICI treatment.
  • Measurable disease including a lesion that is amenable to injection.
  • Able and willing to undergo a pre-treatment and on-treatment biopsy.
  • ECOG Performance status of 0 or 1.
  • 18 years of age or older.
  • Granulocyte count (ANC) ≥ 1,000/mm.
  • Peripheral lymphocyte count ≥ 500/mm.
  • Hemoglobin ≥ 8 g/dl (patients may be transfused to meet this criterion).
  • Platelets ≥ 75,000/mm.
  • Total bilirubin ≤ 1.5 x upper limit of normal, except for patients with known Gilbert disease who must have total bilirubin ≤ 3 x upper limit of normal.
  • SGOT (AST) ≤ 5 x upper limit of normal and if elevated, not clinically significant such that ICI can continue.
  • INR/aPTT within normal limits or, if on anti-coagulation, it must be clinically acceptable to hold anti-coagulation for the injection procedures as appropriate.
  • Serum creatinine < 2 mg/dl and calculated creatinine clearance > 30 ml/min.
  • Clinically eligible and willing to continue ICI.
  • Patients must give study specific informed consent prior to enrollment.

Exclusion Criteria:

  • Patients with a history of severe hypersensitivity reaction to ICI.
  • Patients who require ongoing therapy with systmeic immunosuppressive drugs including systemic corticosteroids (> 10 mg prednisone per day or equivalent) - premedication for ICI or chemotherapy is allowed.
  • Patients with a history of active autoimmune disease requiring treatment in the past 2 years.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active hepatitis, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant, lactating or intend to become pregnant during the study.
  • Patients who are known to be HIV positive.
  • Patients with a history of hypersensitivity or allergic reactions to valacyclovir or acyclovir.
  • Patients with significant heart disease (New York Heart Association Functional Classification III or IV).
  • Patients with oxygen dependence (daily use)
  • Tumor impinging on a neurovascular structure such that inflammation in the site may put patient at risk of compromise as determined by the investigator.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janani Reisenauer, M.D.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kenneth Sakata, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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