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Device

TTFields + Pembrolizumab for Lung Cancer (KEYNOTE B36 Trial)

Phase 2
Recruiting
Research Sponsored by NovoCure GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed, newly diagnosed unresectable stage III or metastatic (M1a) intrathoracic NSCLC without EGFR sensitizing mutation or ALK translocation
Have not received prior systemic treatments for NSCLC.
Must not have
Has received prior systemic anti-cancer therapy for metastatic or current advanced NSCLC (palliative radiotherapy is allowed)
Received live vaccine in the past 30 days or had major surgery in the last 3 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device that sends electric fields to the chest to treat lung cancer along with the drug pembrolizumab. The aim is to see if the combination can help people with lung cancer who haven't been treated before.

Who is the study for?
This trial is for adults aged 22 or older with advanced or metastatic non-small cell lung cancer (NSCLC) that hasn't been treated before. Participants must have a PD-L1 positive tumor and be able to use the NovoTTF-200T device. They should not have certain genetic mutations, untreated brain metastases, or recent major surgery, and cannot be pregnant.
What is being tested?
The study tests Tumor Treating Fields (TTFields) delivered by the NovoTTF-200T alongside pembrolizumab versus pembrolizumab alone in treating NSCLC. It aims to see if adding TTFields improves progression-free survival compared to just the drug treatment.
What are the potential side effects?
Possible side effects include skin irritation from electrode arrays of the TTFields device and typical immune therapy-related issues like fatigue, rash, diarrhea, and potential immune-related complications due to pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is advanced and cannot be removed by surgery, and it does not have certain genetic changes.
Select...
I have not had any drug treatments for my lung cancer.
Select...
My tumor is PD-L1 positive.
Select...
My lung cancer is advanced and does not have certain genetic changes.
Select...
I am 22 years old or older.
Select...
I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had treatment for advanced lung cancer before, but not palliative radiotherapy.
Select...
I haven't had a live vaccine or major surgery in the last 30 days and 3 weeks, respectively.
Select...
I have active or untreated brain metastases or cancer in my brain's lining.
Select...
My cancer has a specific genetic change known as EGFR or ALK.
Select...
I have been treated with specific immune therapy within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Secondary study objectives
Disease control rate (DCR)
Duration of response (DOR)
Objective Response Rate (ORR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Control GroupExperimental Treatment1 Intervention
Pembrolizumab (MK-3475)
Group II: Arm 1: Treatment GroupExperimental Treatment2 Interventions
Pembrolizumab (MK-3475) and TTFields
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NovoTTF-200T
2018
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

NovoCure GmbHLead Sponsor
15 Previous Clinical Trials
3,582 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,031 Previous Clinical Trials
5,189,604 Total Patients Enrolled

Media Library

NovoTTF-200T (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04892472 — Phase 2
Lung Cancer Research Study Groups: Arm 1: Treatment Group, Arm 2: Control Group
Lung Cancer Clinical Trial 2023: NovoTTF-200T Highlights & Side Effects. Trial Name: NCT04892472 — Phase 2
NovoTTF-200T (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04892472 — Phase 2
~23 spots leftby Dec 2025
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