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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 belowSelect...
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
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
NovoCure GmbHLead Sponsor
12 Previous Clinical Trials
2,715 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,910 Previous Clinical Trials
5,066,329 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your disease can be measured using a standard method called RECIST 1.1.My condition can be treated with surgery or chemoradiation aiming for a cure.I have had treatment for advanced lung cancer before, but not palliative radiotherapy.I will not need any cancer treatment other than the study's while participating.My lung cancer is advanced and cannot be removed by surgery, and it does not have certain genetic changes.I have not had any drug treatments for my lung cancer.You cannot use the NovoTTF-200T device by yourself or with help from someone else.I haven't been treated for advanced NSCLC, but may have had treatment over a year ago for early-stage cancer.I haven't had a live vaccine or major surgery in the last 30 days and 3 weeks, respectively.My tumor is PD-L1 positive.I have active or untreated brain metastases or cancer in my brain's lining.My lung cancer is advanced and does not have certain genetic changes.My cancer has a specific genetic change known as EGFR or ALK.I have been treated with specific immune therapy within the last year.I am 22 years old or older.My lung disease can be measured or observed.I can carry out all my daily activities without help.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Treatment Group
- Group 2: Arm 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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