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Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer

NCT04397003 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-10-22

No results posted yet for this study

Summary

The investigators hypothesize that a personalized neoantigen vaccine combined with durvalumab will improve the progression free survival of patients with extensive state small cell lung cancer (ES-SCLC).

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

BIOLOGICAL

Neoantigen DNA vaccine

All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM system, PapiVax Biotech). At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis.

DRUG

Durvalumab

-Supplied by AstraZeneca

DEVICE

TDS-IM v2.0 Device

-Integrated electroporation administration system

PROCEDURE

Peripheral blood draws

-Pre-treatment, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Vaccine Day 1, Vaccine Day 29, Vaccine Day 85, Vaccine Day 141, on even numbers of cycles for durvalumab for one year following completion of vaccine

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Gateway for Cancer Research

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jeffrey Ward, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2027-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04397003 on ClinicalTrials.gov