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Monoclonal Antibodies

TTFields + Pembrolizumab + Chemotherapy for Lung Cancer (LUNAR-2 Trial)

Phase 3
Recruiting
Research Sponsored by NovoCure GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status (PS) of 0-1.
≥22 years of age in the USA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial, called LUNAR-2, is looking at how well a treatment called TTFields, given with the NovoTTF-200T device, works alongside pembrolizumab

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has spread, who are in good physical condition (able to perform daily activities without significant limitations) and have not had previous systemic treatment for their metastatic disease. Women must not be pregnant or breastfeeding, and men must agree to use contraception.
What is being tested?
The LUNAR-2 study tests the combination of TTFields delivered by NovoTTF-200T device with pembrolizumab and platinum-based chemotherapy. It aims to see if this mix can improve survival times for patients compared to current treatments, focusing on different subtypes of lung cancer.
What are the potential side effects?
Possible side effects include those related to pembrolizumab such as immune system reactions affecting organs, infusion-related symptoms; from chemotherapy like nausea, hair loss; and skin irritation or discomfort from the TTFields device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am 22 years old or older.
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I am not pregnant or breastfeeding.
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My lung cancer is stage 4, either non-squamous or squamous.
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My lung disease can be measured by medical imaging.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
1, 2, and 3-year Survival Rate
Adverse Events
Disease Control Rate (DCR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based ChemotherapyExperimental Treatment3 Interventions
Subjects in this arm receive three treatments - TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy.
Group II: Arm 2: Pembrolizumab and Platinum-based ChemotherapyActive Control2 Interventions
Subjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
NovoTTF-200T
2018
Completed Phase 3
~850

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Who is running the clinical trial?

NovoCure GmbHLead Sponsor
15 Previous Clinical Trials
2,916 Total Patients Enrolled
~489 spots leftby Oct 2028
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