A single center and single arm study for personalized neoantigen peptides vaccine in the treatment of advanced non-small cell lung cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800020408

Enrollment

Unknown

Registered

2018-12-28

Start date

2018-11-26

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

Case series:Case series

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients volunteer to join in the trial and sign the informed consents; 2. Adult patients aged 18 to 75 years old, no gender limitation; 3. Histologically confirmed advanced non-small cell lung cancer, TNM stage IIIb-IV; 4. Patients who cannot tolerate chemoradiotherapy or progression after chemoradiotherapy; 5. At least one site of lesion measurable by image examination; 6. with an anticipated life expectancy of 3 months or longer; 7. Hematology Indexes: Serum creatinine = 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; creatinine clearance (CrCl) = 60 mL/min

Exclusion criteria

Exclusion criteria: 1. Known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, or uncontrolled coronary artery diseases, uncontrolled asthma, uncontrolled cerebrovascular diseases, or any other diseases in the opinion of the investigator would compromise study administration; 2. Previous bone marrow transplantation or organ transplantation; Coagulation disorders; 3. History of pre-existing immunodeficiency disorders, or autoimmune diseases; 4. Received any other immunotherapy within the last 30 days; 5. With EGFR, ALK, ROS1 positive mutation; 6. Potential allergic reactions for immunotherapy; 7. Drug abuse or any clinical or psychological or social factors affect informed consent or research implementation; 8. Pregnant or nursing woman; 9. Currently participating or participated other clinical studies within the last 4 weeks; 10. Any underlying conditions that were unsafe for patients or would compromise study administration.

Design outcomes

Primary

Measure	Time frame
Safety Index;	—

Secondary

Measure	Time frame
ORR;OS;PFS;DOR;EORTC QLQ-C30 V3.0;	—

Countries

China

Contacts

Public ContactQiang Li

Dongfang Hospital Affiliated to Tongji University

liqressh@hotmail.com+86 021 6156 9717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026