Recent Updates
Recently added Catalysts

NovoTTF-100L

Phase 4FDA approved 2004

Non-small Cell Lung Cancer | Unknown | Oncology |NovoCure Limited|Trials Updated: Aug 16, 2024

NovoTTF-100L development status

FDA approval Feb 4, 2004 as Alimta
Approval holderLilly
ApplicationNDA021462
Highest phase Phase 4 run by Eli Lilly and Company (NCT00380718)
Phase scored for NVCRPhase 1
Registered trials 365+ across 99 sponsors since Apr 2002

Label indication ALIMTA ® is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. FDA label

NovoTTF-100L target and mechanism

ModalityUnknown

Also known as TTFields, Pemetrexed, Alimta, Electric fields

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment67

FDA Designations

No designations recorded

NovoTTF-100L clinical trials

NovoTTF-100L · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT04492163Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBMGlioblastoma Multiforme
COMPLETED25 Analytics
PHASE2COMPLETED
Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM
Glioblastoma MultiformeUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival (PFS)
18 Months

PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.

Device related toxicity
until 2 months after treatment termination

Secondary Endpoints

Overall Survival (OS)
18 Months
Progression Free Survival at 6 months (PFS6)
18 Months
1-year and 2-year survival rates
24 Months
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental: TTFieldsEXPERIMENTALPatients receive continuous TTFields treatment using the Optune® System with high intensity transducer arrays.
AEXPERIMENTALTreatment with concomitant Alimta and NovoTTF-100L

Interventions

NameTypeDescription
TTFieldsDEVICETTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine. Other Names: • TTFields
NovoTTF-100LDEVICETTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically confirmed diagnosis of GBM according to WHO classification criteria. 2. Age ≥ 18 years 3. Not a candidate for further radiotherapy or additional resection of residual tumor. 4. Patients with first or second radiological disease progression per RANO criteria doc...

Countries:CzechiaSwitzerland
Unlock Eligibility Criteria

Competitive Landscape -Non-Small Cell Lung Cancer 541 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3ABBV-1480, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS12PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
Unlock Competitive Intelligence

Frequently asked questions about NovoTTF-100L

What is NovoTTF-100L used for in Non-small Cell Lung Cancer?

NovoTTF-100L is an investigational device being studied for the treatment of Non-small Cell Lung Cancer (NSCLC). It delivers tumor treating fields, a type of electric field therapy, to the tumor region. In a completed Phase 1 clinical trial, it was evaluated in combination with the chemotherapy drug pemetrexed (Alimta) for advanced NSCLC.

Who makes NovoTTF-100L?

NovoTTF-100L is developed by NovoCure Limited, a company traded on the NASDAQ under the ticker symbol NVCR. NovoCure specializes in tumor treating fields therapy, and NovoTTF-100L is one of its investigational devices being studied for oncology applications.

What phase is NovoTTF-100L in?

NovoTTF-100L is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. A Phase 1 trial has been completed, but the device remains in early-stage clinical investigation for Non-small Cell Lung Cancer.

What clinical trials is NovoTTF-100L in?

NovoTTF-100L has been studied in one completed Phase 1 clinical trial, identified as NCT00749346. This trial evaluated NovoTTF-100L in combination with pemetrexed (Alimta) for advanced Non-small Cell Lung Cancer. The trial enrolled 42 participants and was conducted in Switzerland.

How does NovoTTF-100L work?

NovoTTF-100L works by delivering tumor treating fields, which are low-intensity electric fields that disrupt cancer cell division. This mechanism is intended to inhibit tumor growth. The device is applied externally and is being studied in combination with chemotherapy for Non-small Cell Lung Cancer.