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
treatment
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. Within 6 months of enrollment, no change of ICI therapy or prior interruptions of more
than 4 weeks of current ICI
15. Patients should not have received focal therapy (e.g., radiotherapy) at more than
three different sites of disease within 12-months prior to enrollment
16. Patients must give study specific informed consent prior to enrollment and any study
specific procedures
Exclusion Criteria:
1. Patients with a history of severe immune related adverse events related 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
years
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
acyclovir
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
longer
16. Patients must have no concurrent malignancy requiring treatment (except squamous or
basal cell skin cancers)
17. Patients without contrast enhanced imaging at baseline or those with contraindication
to the use of contrast.
18. Patients who are pregnant, breastfeeding, or plan to become pregnant.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 7/18/23. Questions regarding updates should be directed to the study team contact.