non-small cell lung cancer
Conditions
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The clinical stage confirmed by histology or cytology is stage IV or recurrent non-small cell lung cancer; 2. Failure to receive anti-PD-1 antibody monotherapy in the past, remission of anti-PD-1 antibody treatment, or disease progression with stable disease for >=3 months; 3. Aged 18-75 years, gender is not limited; 4. There must be at least one injectable lesion or a lesion >=2cm, and the lesion must meet the requirements of RECIST 1.1 and iRECIST measurable target lesions; 5. ECOG score is 0-2; 6. PD-L1 expression >= 1% (post-line patients do not need mandatory testing); 7. Expected survival period >= 3 months; 8. Laboratory tests must meet the following standards: (1) White blood cell count >=3.0x10^9/L, absolute value of neutrophils >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90g/L; (2) INR=50ml/min; 9. The patients voluntarily signed the informed consent form, with good compliance, and cooperated with the follow-up; 10. Females of childbearing age should take effective contraception during the study period and within 3 months after the end of the study treatment period; non-surgical sterilization female patients of childbearing age must have negative serum or urine HCG tests within 7 days before study enrollment. Male patients and their partners must agree to use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Tumors with mixed histology including SCLC complexes or non-small cell lung cancers that have not received anti-PD-1 antibody therapy; 2. Known EGFR driver gene positive or HER2 exon insertion; 3. ALK or ROS1 gene rearrangement was found by IH, FISH or NGS sequencing; 4. Those who are known to be allergic to the study drug or its active ingredients and excipients, allergic to chimeric or humanized antibodies, fusion proteins and components, and have a history of allergy to similar oncolytic virus biological agents; 5. History of active autoimmune disease or autoimmune disease that may recur; 6. Uncontrollable tumor-related pain; 7. Previous treatment with oncolytic virus drugs or similar drugs (such as T-VEC); 8. The local lesions cannot meet the requirements of intratumoral injection volume or are not suitable for intratumoral injection; 9. Associated with malignant pleural effusion and ascites; 10. Other malignant tumors in the past or at the same time (except malignant tumors that have been cured or have survived cancer-free for more than 5 years, such as skin basal cell carcinoma, cervical carcinoma in situ and papillary thyroid carcinoma, etc.); 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 cardiac arrhythmia, liver, kidney, or metabolic disease requiring medication; 12. Within 4 weeks before enrollment or planning to receive antiviral (such as acyclovir, ganciclovir, valaciclovir, vidarabine, etc.) or attenuated vaccine treatment during the study; 13. Taking immunosuppressive drugs within 4 weeks before enrollment, excluding: intranasal inhaled topical steroid therapy or topical steroid injection (such as intra-articular injection); systemic steroid therapy not exceeding 10 mg/day of prednisone or other equivalent physiological doses; glucocorticoids as preventive medication for allergic reactions (eg, before chemotherapy); 14. Received any other experimental drugs, antibacterial drugs or participated in another interventional clinical trial within 4 weeks before enrollment; 15. Pregnant or lactating patients; 16. According to the judgment of the investigator, the patient has other factors that may cause the study to be terminated midway, such as other serious diseases, serious laboratory abnormalities, accompanied by other family or social factors that will affect the safety of the subjects or the test data and sample collection; 17. Any mental condition that prevents understanding or providing informed consent; 18. Other conditions deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Quality of life score; | — |
Countries
China
Contacts
Public ContactMiao Liyun
Nanjing Drum Tower Hospital
Outcome results
None listed