Patients with locally advanced or metastatic non - small cell lung cancer who have experienced treatment failure in second - line or higher standard treatment or are intolerant to the adverse effects of standard treatment.
Conditions
Interventions
YMN-RP01 Vaccine Dose Group 1:YMN-RP01 vaccine 2.0x10^10 VP/dose, intranasal administration, once every 21 days for 3 doses
YMN-RP01 Vaccine Dose Group 2:YMN-RP01 vaccine 4.0x10^10 VP/dose, intranasal administration, once every 21 days for 3 doses
YMN-RP01 Vaccine Dose Group 3:YMN-RP01 vaccine 8.0x10^10 VP/dose, intranasal administration, once every 21 days for 3 doses
YMN-RP01 Vaccine Combined with PD-1 Monoclonal Antibody Treatment Group:YMN-RP01 vaccine (RP2D dose) + Pembrolizumab 200mg, intranasal + intravenous infusion, once every 21 days for 3 doses
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Sign a written informed consent form( Clinical research participants must sign a written informed consent form approved by the ethics committee, in accordance with the regulations and institutional guidelines ; The informed consent form must be signed and dated prior to any study-related procedures that are not part of routine clinical care for the clinical research participants.(2).Clinical research participants must be willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other requirements of the study); 2)Male or female : >=18 years old and = 90 g/L (no blood transfusions within 14 days); Neutrophil count > 1.5 × 10^9/L; Platelet count >= 80 × 10^9/L;• Biochemical examination: Total bilirubin = 50 ml/min (Cockcroft-Gault formula) or creatinine level = 50%.• QTcF interval, male <= 470 ms, female <= 450 ms, QTc interval calculated using Fridericia's formula; 10) Premenopause women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation, and must not be breastfeeding; all participants in the clinical study (regardless of gender) should apply effective barrier contraception throughout treatment an
Exclusion criteria
Exclusion criteria: 1)Received other unapproved clinical trial drugs or treatments within 4 weeks prior to enrollment; 2) Clinical trial participants with a history of other malignancies, except for situ cervical cancer, treated skin squamous cell carcinoma, bladder epithelial tumors, or other malignant tumors that have already undergone curative treatment (at least 5 years prior to enrollment); 3)History of severe cardiovascular or cerebrovascular diseases, such as: NYHA class II or higher heart failure, acute coronary syndrome (unstable angina, myocardial infarction, etc.) and acute cerebrovascular disease (such as cerebral infarction, cerebral hemorrhage, etc.)within 6 months before screening, frequent and uncontrolled severe arrhythmias; 4)History of autologous or allogeneic stem cell transplantation; 5)Active pulmonary tuberculosis or presence of active severe infection within 14 days prior to enrollment; HIV infection, active HBV infection (positive hepatitis B surface antigen and HBV-DNA > 500 IU/ml), active HCV infection; 6)History of substance abuse or severe neurological/psychiatric disorders (e.g., alcoholism, depression, schizophrenia, epilepsy); 7)Clinical research participants who have any active autoimmune disease or a history of autoimmune disease (including but not limited to: dermatomyositis, rheumatoid arthritis, systemic lupus erythematosus, etc.); participants with vitiligo or those whose childhood asthma has completely resolved without any intervention in adulthood can be included; those requiring bronchodilators are excluded); 8)Patients with contraindications to nasal spray injection therapy. 9)History or evidence of interstitial lung disease requiring glucocorticoid therapy, or suspected interstitial lung disease; 10)Unstable central nervous system metastases, meningeal metastases, or spinal cord compression; 11)Previous use of chemotherapy, targeted therapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, extensive radiotherapy (more than 30% bone marrow) within 4 weeks or 5 half-lives (whichever is shorter), or palliative radiotherapy (allowing for palliative radiotherapy to bone lesions) within 2 weeks; 12)Received a live vaccine within 28 days before planned vaccination or treatment study. 13)Known allergies and hypersensitivity reactions to vaccine research (including any adjuvants), or history of severe allergic reactions to any drugs, foods, or vaccines, such as anaphylaxis, angioedema, dyspnea, purpura, Arthus reaction, etc; 14)Any other severe medical condition that, in the investigator’s judgement, may compromise subject safety or interfere with study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response(DOR);Objective response rate (ORR);Disease control rate(DCR);Progression free survival(PFS);An initial exploration of the specific immune response against RPLP0 induced after the monotherapy with the YMN - RP01 vaccine and the combination therapy of the YMN - RP01 vaccine and the PD - 1 mono;Overall survival(OS); | — |
Countries
China
Contacts
Public ContactHuang Meijuan
West China Hospital of Sichuan University
Outcome results
None listed