non-small cell lung cancer
Conditions
Sponsors
Shanxi Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years old, age =75 years old, gender unlimited; 2) advanced non-squamous NSCLC confirmed by histopathology or cytology; 3) Previous anti-PD -(L)1 antibody therapy failed (including PD-(L)1 monotherapy and combination regimen), anti-PD -(L)1 antibody therapy achieved remission or disease progression occurred after =6 months of disease stabilization; 4) Subjects previously treated with PD-(L)1 should not discontinue treatment due to any TRAEs, including immune-related adverse events. Prior treatment-related adverse events should also be fully resolved and no treatment required for at least 28 days prior to enrollment; 5) There must be at least one injectable lesion or lesion =2cm, and the lesion must comply with RECIST 1.1 measurable target lesion; 6) ECOG PS 0-2; 7) Expected survival =3 months; 8) Signed informed consent voluntarily, expected compliance is good, can cooperate with follow-up; 9) Laboratory examination must meet the following standards: ? WBC=3.0 x 109 / L , neutrophil=1.5 x 109 / L, PLT=100 x 109 / L, HGB=90 g/L; ? INR=1.5 , or the APTT=1.5 x ULN; ? total bilirubin=1.25 x ULN; ALT and AST=5 x ULN; ? CrCl=50 ml/min;
Exclusion criteria
Exclusion criteria: 1) Diagnosis of small cell lung cancer, or mixed histological tumors with SCLC; 2) Exclude patients with active and symptomatic BMS; 3) Patients with known EGFR or ALK gene mutation positivity; 4) Past treatment with oncolytic virus drugs or similar drugs (such as T-VEC); 5) Local lesions cannot meet the requirements of intratumoral injection volume or are not suitable for intratumoral injection; 6) Known allergy to the investigational drug or its active ingredients and components; 7) Active autoimmune disease or a history of recurrent autoimmune disease; 8) Uncontrolled tumor-related pain; 9) accompanied by malignant hydrothorax and ascites; 10) Previous or co-existing malignancies (except those that have been cured or have survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid); 11) The patient has any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic disease; 12) Receiving antiviral (e.g. Acyclovir, ganciclovir, valaciclovir, adenosine arabidase, etc.) or attenuated vaccine within 4 weeks prior to enrollment or during the study period; 13) Immunosuppressive drugs were taken within the first 4 weeks of enrollment, but did not include: intranasal inhalation local steroid therapy or local steroid injection (such as intraarticular injection); 14) systemic steroid therapy not exceeding 10mg/ day prednisone or other equivalent physiological dose; Glucocorticoids as prophylactic for allergic reactions (e.g., before chemotherapy); 15) Received any other investigational drug, antibacterial drug or participated in another interventional clinical trial within 4 weeks prior to enrollment; 16) Pregnant or lactating women; 17) In the investigator's judgment, the patient had other factors that might have led to the termination of the study, such as other serious medical conditions, serious abnormalities in laboratory tests, and other family or social factors that would have affected the subject's safety or the collection of test data and samples; 18) Any mental condition that prevents understanding or providing informed consent; 19) Other conditions deemed inappropriate for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;objective response rate, ORR;Duration of Response;Quality of life score; | — |
Countries
China
Contacts
Public ContactGuo Wei
Shanxi Provincial Cancer Hospital
Outcome results
None listed