Health TrialsbyHealthPanel

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

ConditionAdvanced NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically or cytologically confirmed advanced NSCLC who require radiotherapy for metastatic lesions;

At least one measurable lesion;

Aged 18-70, regardless of gender;

Disease progression after standard second-line therapy, and more than 2 weeks since the end of the last antitumor treatment;

Disqualifiers

Patients with uncontrollable brain metastases;

Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or surgical resection.

Subjects who have required systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;

Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    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.

  • PD-1 inhibitor

    Drug

    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.

  • Neoantigen-based peptide vaccine

    Drug

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Combinational treatment of radiotherapy, PD-1 inhibitor, and neoantigen-based peptide vaccineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

According to RECIST (version 1.1) criteria, the proportion of subjects experiencing Complete Response (CR) or Partial Response (PR) within the analyzed population. Provide the 95% CI for the Objective Response Rate (ORR).

Time frame
Through study completion, an average of 30 weeks
2

Disease control rate (DCR)

According to RECIST (version 1.1) criteria, the proportion of subjects experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) within the analyzed population. Provide the 95% CI for the Disease Control Rate (DCR).

Time frame
Through study completion, an average of 30 weeks
3

Drug safety

Safety analysis will be based on data from the safety population. It will primarily involve descriptive statistical analysis, with tables describing the adverse events that occurred in this study.

Time frame
Through study completion, an average of 30 weeks

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) is defined as the time from the first administration of the study drug to disease progression or death. For subjects who have not reported disease progression at the time of analysis, the date of their last disease progression-free check will be used as the censoring date. The median PFS and its 95% CI will be analyzed using the Kaplan-Meier method, and survival curves will be plotted.

Time frame
From date of recruiting until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 months
2

Overall Survival (OS)

Overall Survival (OS) is defined as the time from the first administration of the study drug to death from any cause. For subjects who have not reported death at the time of analysis, the date of their last known survival will be used as the censoring date. The median OS and its 95% CI will be analyzed using the Kaplan-Meier method, and survival curves will be plotted.

Time frame
From date of recruiting until the date of death from any cause, whichever came first, assessed up to 66 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Nanchang University

Lead sponsor

Source ClinicalTrials.gov
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