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NCT03380871 · ClinicalTrials.gov registry record · Phase 1

A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer

A Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by BioNTech US.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target
5
Study locations

NCT03380871 is a Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung that has completed, run by BioNTech US. The registered enrollment target is 38 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT03380871, a Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, has completed, sponsored by BioNTech US.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target
5
Study locations

Study Summary

The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial.

Conditions Studied

Lung Cancer Carcinoma, Non-Small Cell Lung Nonsquamous Nonsmall Cell Neoplasm of Lung

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Carboplatin
  • DRUG Pemetrexed
  • BIOLOGICAL NEO-PV-01
  • OTHER Adjuvant

Study Locations (5)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

California

  • University of California - Los Angeles - Santa Monica

Missouri

  • Washington University in St. Louis - St Louis

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2018-05-04
Est. Completion 2021-02-05
Phase Phase 1

Sponsor

BioNTech US

3 total trials

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What the Registry Record Tells You About NCT03380871

The ClinicalTrials.gov registry entry for NCT03380871 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The listed sponsor is BioNTech US, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT03380871 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT03380871 about?

NCT03380871 is a clinical study titled "A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer". The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemo...

What is the current status of trial NCT03380871?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2018-05-04. Estimated completion is 2021-02-05.

What conditions does trial NCT03380871 study?

This clinical trial studies the following conditions: Lung Cancer, Carcinoma, Non-Small Cell Lung, Nonsquamous Nonsmall Cell Neoplasm of Lung.

What interventions are being tested in trial NCT03380871?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Pemetrexed (DRUG), NEO-PV-01 (BIOLOGICAL), Adjuvant (OTHER).

Who is sponsoring clinical trial NCT03380871?

This trial is sponsored by BioNTech US, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03380871 being conducted?

This trial has 5 study locations across California, Massachusetts, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.