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


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:

1. Patients with Stage III/IV NSCLC on first line treatment with anti-PD-1/PD-L1 (ICI)
+/- chemotherapy for their current stage of disease and fits into one of the following
cohorts as determined by investigator, preferably as per RECIST 1.1: Cohort 1) have
persistent but stable disease at least 18 weeks after starting ICI treatment, or
Cohort 2) have radiographic progressive disease at least 18 weeks after starting ICI

2. RECIST evaluable disease including a lesion that is amenable to injection

3. Able and willing to undergo a pre-treatment and on-treatment biopsies, if feasible

4. ECOG Performance status of 0 or 1

5. 18 years of age or older

6. Granulocyte count (ANC) ≥ 1,000/mm3

7. Hemoglobin ≥ 8 g/dl (patients may be transfused to meet this criterion)

8. Platelets ≥ 75,000/mm3

9. 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

10. SGOT (AST) ≤ 5x upper limit of normal and if elevated, not clinically significant such
that ICI can continue

11. INR no more than 0.2 above upper limit of normal and aPTT not >1.2 x upper limit of
normal, and value is acceptable for patient to undergo injection procedure. If on
anti-coagulation, it must be clinically acceptable to hold anti-coagulation for the
injection procedures per investigator discretion

12. Serum creatinine < 2mg/dl and calculated creatinine clearance > 30ml/min

13. Clinically stable and able to continue ICI for at least the 12-week treatment period

14. Patients must give study specific informed consent prior to enrollment and any study
specific procedures

Exclusion Criteria:

1. Patients with a history of severe hypersensitivity reaction to ICI

2. Patients who require ongoing therapy with disease-modifying antirheumatic drugs
(DMARDs), immunomodulators or systemic immunosuppressive drugs including systemic
corticosteroids (>10 mg prednisone per day or equivalent) - premedication for ICI or
chemotherapy is allowed

3. Patients with a history of active autoimmune disease requiring treatment in the past 2

4. 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

5. Women who are pregnant, lactating or intend to become pregnant during the study

6. Patients who are known to be HIV positive

7. Patients with a history of hypersensitivity or allergic reactions to valacyclovir or

8. Patients with significant heart disease (New York Heart Association Functional
Classification III or IV)

9. Patients with continuous oxygen dependence >2L/min at rest

10. Tumor impinging on a neurovascular structure such that inflammation in the site may
put patient at risk of compromise as determined by the investigator

11. Patients with uncontrolled brain metastases as per investigator

12. Patients with liver metastases involving more than half of the liver

13. Patients with known EGFR mutation, ALK fusion, or ROS1 fusion positive NSCLC, or that
are receiving tyrosine kinase inhibitor (TKI) agents/ALK/ROS1 inhibitors

14. Patients with known interstitial lung diseases (ILDs) requiring active therapy
(Radiographic fibrosis not requiring therapy is allowed)

15. Patients receiving vascular endothelial growth factor (VEGF) inhibitors (including
bevacizumab, ramucirumab) within the past 2 months or five half-lives, whichever is

16. Patients must have no concurrent malignancy requiring treatment (except squamous or
basal cell skin cancers)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/28/22. Questions regarding updates should be directed to the study team contact.

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


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