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Chemotherapy

Device Duration Level 1 for Non-Small Cell Lung Cancer (NOVOCURE Trial)

Phase 1

Recruiting

Led By Wallace Akerley, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year 6 months

Awards & highlights

NOVOCURE Trial Summary

This trial will test the safety of a new treatment for Non-Small Cell Lung Cancer (NSCLC). Patients will receive chemo, radiation, and a new device with immunotherapy.

Who is the study for?

This trial is for adults with stage IIIA or IIIB non-small cell lung cancer (NSCLC) that can't be removed by surgery. Participants should have recovered from any previous radiation-induced pneumonitis, be able to use the NovoTTF-200T System independently or with help, and meet specific health criteria including organ function. Pregnant individuals or those not recovered from prior cancer therapies are excluded.Check my eligibility

What is being tested?

The study tests the safety of Tumor Treating Fields (TTFields) combined with standard chemoradiation and durvalumab in NSCLC patients. It has two steps: first, TTFields with chemoradiation; second, adding durvalumab post-chemoradiation. The main focus is on dose-limiting toxicities during treatment.See study design

What are the potential side effects?

Possible side effects include skin irritation beneath device electrodes, fatigue due to chemotherapy and immunotherapy, potential immune-related reactions from durvalumab like inflammation in organs, as well as typical chemo side effects such as nausea and low blood counts.

NOVOCURE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period

Secondary outcome measures

Overall survival (OS) as defined as the time from CRT until death from any cause.

Progression-free survival as defined as the time from CRT to the time documented disease progression (as assessed by RECIST 1.1) or death from any cause.

The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment

NOVOCURE Trial Design

2Treatment groups

Experimental Treatment

Group I: Device Duration Level 2Experimental Treatment3 Interventions

Participants in in Device Duration Level 2 will begin TTF therapy during SOC durvalumab and SOC Concurrent chemoradiation following Device Duration Level 1.

Group II: Device Duration Level 1Experimental Treatment2 Interventions

Participants in Device Duration Level 1 will receive Tumor Treatment Fields (TTF) therapy during standard of care consolidation durvalumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,102 Previous Clinical Trials

1,779,231 Total Patients Enrolled

Wallace Akerley, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

4 Previous Clinical Trials

198 Total Patients Enrolled

Sonam Puri, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial ongoing at the present time?

"As per clinicaltrials.gov, this trial is not actively recruiting patients at present. It was initially posted on November 15th 2023 and last revised on the 3rd of that month. Although it is unavailable to join currently, there are 1,569 other trials accepting participants presently."

Answered by AI