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Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

Phase II Study of a Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer

NCT04397003•Washington University School of Medicine

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC)
•Considered suitable to receive a platinum-based chemotherapy regimen with durvalumab as 1st line treatment for ES-SCLC.
•Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
•At least one lesion must be able to be biopsied at the time of enrollment. The site utilized for biopsy cannot be utilized as a target lesion for efficacy measurement.
•At least 18 years of age.
•ECOG performance status ≤ 1
•Life expectancy of at least 12 weeks.
•Body weight \> 30 kg.
•Adequate normal organ and marrow function as defined below:
•* Hemoglobin ≥ 9.0 g/dL
+41 more criteria

Exclusion Criteria

•Prior treatment with a PD-1 or PD-L1 inhibitor (including durvalumab).
•A history of other primary malignancy except for:
•* Malignancy treated with curative intent and with no know active disease ≥ 5 years before the first dose of study drug and of low potential risk for recurrence
•* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•* Adequately treated carcinoma in situ without evidence of disease
•Currently receiving any other investigational agents.
•Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
•Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
•Is an individual in whom the ability to observe possible local site reactions at \>2 eligible injection sites (left and right medial deltoid or left and right vastus lateralis muscles) is, in the opinion of the investigator, unacceptably obscured due to a physical condition.
•Has a metal implant or implantable device within the area of the electroporation injection site at \>2 of the eligible injection sites.
+19 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

March 30, 2022

Primary Completion Date

September 30, 2027

Completion Date

September 30, 2029

Last Updated

October 22, 2025

Enrollment

ACTUAL participants

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

Neoantigen DNA vaccine

BIOLOGICAL

Durvalumab

DRUG

TDS-IM v2.0 Device

DEVICE

Peripheral blood draws

PROCEDURE

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

NCT06646276

Extensive-Stage Small Cell Lung Cancer

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NOT_YET_RECRUITINGPHASE1/PHASE2

Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer

NCT07328490

Extensive-Stage Small Cell Lung CancerExtrapulmonary Neuroendocrine Carcinoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer

Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer

Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase

Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-Stage Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm Phase II Clinical Study

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411