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Osimertinib

Phase 2

Non Small Cell Lung Cancer | Small molecule | Oncology |Third Harmonic Bio, Inc.|Last Updated: May 30, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment137
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06436144Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLCPHASE2 NOT YET_RECRUITING 93Jun 1, 2024Dec 1, 2029May 30, 2024 -
NCT06018688Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.PHASE2 NOT YET_RECRUITING 44Sep 15, 2023Sep 1, 2026Sep 21, 2023 -
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Study Endpoints
Primary Endpoints
Objective Remission Rate (ORR) as assessed by RECIST v1.1
Within 1 month after treatment

To evaluate the efficacy of osimertinib combined with etoposide as first-line treatment in patients with osimertinib-resistant or -insensitive, advanced EGFR-mutant non-small cell lung cancer. ORR will be defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.

Major pathologic response
Within 1 month after surgery

MPR refers to the percentage of residual viable tumor cells within the tumor bed after neoadjuvant treatment, with a threshold of ≤10%, regardless of the presence of residual viable tumor cells in the lymph nodes.

Secondary Endpoints
Two-Year Overall Survival Rate
Up to 2 years after the start of treatment
One-Year Progression-Free Survival Rate
Up to 1 year after the start of treatment
Disease Control Rate (DCR) within One Month
Within 1 month after treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Osimertinib Combined With Etoposide Soft CapsuleEXPERIMENTAL -
osimertinib and aspirinEXPERIMENTALOsimertinib and Aspirin starting at a dose of 80 mg and 100mg once a day, orally with meals.The participants will undergo a two-month combination therapy, unless there is tumor progression (worsening) or intolerable toxic reactions that necessitate early termination of the drug treatment. Aspirin will be discontinued one week prior to the surgery.
Interventions
NameTypeDescription
OsimertinibDRUGEtoposide Soft Capsules Dosage:25mg/tablet, 2 tablets/time, taken continuously for 21 days, and stopped for one week. Osimertinib Dosage:80mg/tablet, 1 tablet/time, QD, taken for two cycles.
AspirinDRUGAspirin, also known as acetylsalicylic acid (ASA), is a verysafe medication used to treat pain,fever, or inflammation.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Age 18 to 79 years. 2. Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC. 3. Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R). 4. Received at least two cycles of first-line osimertinib treatment, with a best response of stable disease ...

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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
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06018688studyFirstPostDate: changed
LOWMay 24, 2026NCT06436144studyFirstPostDate: changed