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Device
Tumor Treating Fields for Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by NovoCure Ltd.
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new, portable device that uses electric fields to treat stage 4 NSCLC that has progressed after other treatments.
Who is the study for?
This trial is for adults over 22 with stage 4 non-small cell lung cancer (NSCLC) that has worsened after platinum-based treatment. They should have a life expectancy of at least 3 months, an ECOG Score of 0-2, and be able to use the NovoTTF-200T device. Patients can't join if they have severe illnesses affecting blood, liver or kidneys; allergies to adhesives; electronic devices in their chest; certain heart conditions; untreated brain metastases; or are pregnant.
What is being tested?
The trial tests the safety and effectiveness of TTFields using NovoTTF-200T alongside standard treatments like immune checkpoint inhibitors or docetaxel for NSCLC patients post-platinum failure. It's randomized: some get TTFields plus standard care while others get only standard care.
What are the potential side effects?
Possible side effects include skin irritation beneath device electrodes, headaches, malaise, and interference with wound healing. Standard therapies may cause immune-related reactions, fatigue, hair loss from docetaxel and other chemotherapy-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: NovoTTF-200TExperimental Treatment2 Interventions
Patients receive TTFields using the NovoTTF-200T device together with immune checkpoint inhibitors or docetaxel
Group II: Best Standard of CareActive Control1 Intervention
Patients receive best standard of care with immune checkpoint inhibitors or docetaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NovoTTF-200T
2018
Completed Phase 3
~850
Immune checkpoint inhibitors or docetaxel
2016
Completed Phase 3
~280
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Who is running the clinical trial?
NovoCure Ltd.Lead Sponsor
62 Previous Clinical Trials
5,714 Total Patients Enrolled
NovoCure GmbHLead Sponsor
15 Previous Clinical Trials
3,406 Total Patients Enrolled
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