Recent Updates
Recently added Catalysts

of hyperpolarized xenon gas

Phase 2

Non-small Cell Lung Cancer | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Feb 23, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02151604Hyperpolarized Xenon Gas MR Imaging in NSCLC RadiotherapyPHASE2 COMPLETED 22 — — Apr 23, 2014Dec 31, 2020Feb 23, 20231 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With a Change From Baseline in Ventilation Map Using Hyperpolarized Xe-129 MR Imaging
Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan (range: 7 days to 60 days). For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.

Number of participants with a change from baseline in ventilation map using hyperpolarized Xe-129

Secondary Endpoints
Number of Participants With a Change in Ventilation and ADC Maps Using Hyperpolarized Xe-129 MR Imaging From Baseline to 3 Months Post Radiotherapy Completion
3 months after completion of treatment
Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)
Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan - Range: 7-60 days.) For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
129 Xenon MR ImagingEXPERIMENTALXenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Interventions
NameTypeDescription
Inhalation of hyperpolarized xenon gasDRUGThe xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the trial * Male or Female, aged 18 years or above * Histologically verified NSCLC * Patients with any stage NSCLC where radical radiotherapy (with either conventionally fractionated treatment or wit...

Countries:United Kingdom
Unlock Eligibility Criteria
Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
Unlock Competitive Intelligence