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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

KEYNOTE B36 Trial 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.Check my eligibility

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.See study design

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.

KEYNOTE B36 Trial 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.

KEYNOTE B36 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

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

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DOR)

Objective Response Rate (ORR)

+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

KEYNOTE B36 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

NovoCure GmbHLead Sponsor

11 Previous Clinical Trials

2,639 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,957 Total Patients Enrolled

Media Library

NovoTTF-200T (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04892472 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Arm 1: Treatment Group, Arm 2: Control Group

Non-Small Cell 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

Frequently Asked Questions

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

What is the current status of FDA authorization for NovoTTF-200T?

"Our team at Power evaluated the safety of NovoTTF-200T as a 2 on a 1 to 3 scale. This is because, despite some evidence supporting its security profile, there are no studies that have established efficacy."

Answered by AI

Are there vacancies still open for the participants of this experiment?

"Affirmative. The information present on clinicaltrials.gov confirms that the recruitment process for this trial is ongoing, with an initial posting date of July 12th 2021 and most recent update occurring on September 23rd 2022. 66 participants are sought from a total of 23 sites."

Answered by AI

Are there any Canadian health centers hosting this inquiry?

"At this time, the research is being conducted at Saint Elizabeth Healthcare in Edgewood, Kentucky; Parkview Research Center in Fort Wayne, Ohio; Aultman Hospital in Canton, Texas and 20 other sites."

Answered by AI

How many participants are being observed in this trial?

"To reach the 66 participant quota, individuals who meet this trial's criteria will be enrolled at diverse locations like Saint Elizabeth Healthcare in Edgewood, Kentucky and Parkview Research Center in Fort Wayne, Ohio."

Answered by AI