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NovoCure Ltd (NVCR)
NASDAQ:NVCR
Pembrolizumab, Temozolomide, Optune® Device
Glioblastoma
Phase III
Recruiting
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Aug 13, 2024
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Pembrolizumab, Novottf-200T
Non-Small Cell Lung Cancer (Nsclc)
Phase II
Recruiting
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
Jul 31, 2024
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Gemcitabine, Nab-paclitaxel, Atezolizumab, Tumor Treating Fields
Metastatic Pancreatic Ductal Adenocarcinoma
Phase II
Active Not Recruiting
EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma
Feb 29, 2024
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Pembrolizumab, Novottf-200T, Platinum Based Chemotherapy
Metastatic Non-Small Cell Lung Cancer
Phase III
Recruiting
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
Dec 29, 2023
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Novottf-200T, Pembrolizumab (Mk-3475) 200 Mg
Non-small Cell Lung Cancer
Phase II
Terminated
EF-36/Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer
May 13, 2021
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Sorafenib, Novottf-100L(P) Device
Hepatocellular Carcinoma
Phase II
Completed
Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Sorafenib for Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA)
Jul 23, 2018
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Gemcitabine, Nab Paclitaxel, Novottf-200T
Pancreas Adenocarcinoma
Phase III
Completed
Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Dec 06, 2017
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Best Standard Of Care, Novottf-200M Device
Brain Metastases From Non-Small Cell Lung Cancer (Nsclc)
Phase III
Completed
Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).
Jul 08, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does NovoCure Ltd (NVCR) have in its pipeline
NVCR is currently developing the following drugs: Pembrolizumab, Temozolomide, Optune® Device, Pembrolizumab, Novottf-200T, Gemcitabine, Nab-paclitaxel, Atezolizumab, Tumor Treating Fields. These drug candidates are in various stages of clinical development as the company works toward FDA approval.