Non-small cell lung cancer
Conditions
Interventions
Study group A (EGFR wild type):Subcutaneous injection of personalized neo-antigen peptides vaccine in both arms, once a week for 12 weeks, continued treatment is left to the investigators' discretion
Study group B (EGFR mutation):Subcutaneous injection of personalized neo-antigen peptides vaccine in both arms, once a week for 12 weeks, continued treatment is left to the investigators' discretion
Study group C (EGFR mutation):EGFR-TKI (specification standard dose) +personalized neo-antigen peptides vaccine (subcutaneous injection in both arms, once a week for 12 weeks), continued treatment is
Sponsors
Tianjin Beichen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. III or IV stage patients with locally advanced or metastatic non-small cell lung cancer; 2. EGFR-TKI resistance or progress after surgery or radiotherapy or chemotherapy; 3. One measurable tumor or more, which is evaluated by RECIST (Response Evaluation Criteria in Solid Tumors); 4. Adult patients aged 18 or more; 5. expected survival time months or more; 6. Eastern Cooperative Oncology Group(ECOG) is 0 to 3; 7. Biopsy samples or pathology slice available, and more than one genetic mutation ; 8. No previous immunotherapyIncluding PD-1, anti-PD-L1 or anti-PD-L2 drugs or T cell receptor (such as CTLA-4OX-40CD137) drugs, peptide/mRNA neoantigen Immunotherapy and cell therapy; 9. Be able to follow the research program and follow up process; 10. To be able to and willing to give witnessed, written informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation woman; 2. Patients with known or suspected autoimmune disease or other complicated immune system disease; 3. Systemic cytotoxic chemotherapy or experimental drugs for metastatic NSCLC within 4 weeks prior to first dose of study agent (not including EGFR-TKI); 4. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent; 5. Patients with liver and kidney dysfunction, severe heart disease, coagulation dysfunction and hematopoietic impairment; 6. Patients with active infections requiring systemic treatment; 7. Suffering from other malignancies in progress or accepting active treatment in the past five years; 8. Influence the safety or compliance of the patients; 9. Any disease, treatment, laboratory examination abnormality or medical history that may affect the results of this study or affect the participants' inability to participate in the entire study, or the researchers believe that such subjects are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;feasibility; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological indexes;Tumor markers;ECOG score;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXueming Du
Tianjin Beichen Hospital
Outcome results
None listed