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RECRUITING
NCT06751901
PHASE2

Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment

Sponsor: The First Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after second-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.

Official title: Personalized Tumor Neoantigen-based Peptide Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-03-11

Completion Date

2026-06-10

Last Updated

2024-12-30

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Radiotherapy

Radiotherapy will be completed prior to the administration of personalized tumor neoantigen-based peptide vaccine and PD-1 inhibitors. The treatment cycle, frequency, and dosage are determined by the subject's primary physician based on the specific conditions of the participant.

DRUG

PD-1 inhibitor

Treatment with PD-1 inhibitors will begin after the completion of radiotherapy, with a treatment cycle of 3 weeks. On the first day (D1) of each treatment cycle, the drug is administered intravenously, with the dosage according to the instructions.

DRUG

Neoantigen-based peptide vaccine

The treatment with personalized tumor neoantigen-based peptide vaccine is divided into two periods: the primary phase and the boost phase. The primary phase consists of 6 treatments, with the first 3 treatments spaced one week apart and the subsequent 3 treatments spaced two weeks apart. Vaccine will be administrated on the fourth day (D4) of that week. The boost phase consists of 4 treatments, each spaced three weeks apart. Vaccine will be administrated on the fourth day (D4) of that week.

Locations (2)

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Nanchang

Nanchang, Jiangxi, China