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ZD1839

Phase 3

Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 4, 2013

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034879Iressa Expanded Access Program (EAP)PHASE3 COMPLETED -Aug 1, 2000Oct 1, 2003Jan 4, 2013626 United States
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ZD1839 (Gefitinib)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites626

Inclusion Criteria For inclusion in this trial, patients must fulfill all of the following criteria: * previous documented histologically or cytologically confirmed non-small cell lung cancer; * locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients wh...

Countries:United States
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Competitive Landscape -Cholangiocarcinoma 58 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN11PHASE3Rilvegostomig, Capecitabine, Gemcitabine/Cisplatin, S-1, Durvalumab
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE3Zanidatamab, Cisplatin, Gemcitabine, Pembrolizumab, Durvalumab
Eli Lilly and CompanyLLY4PHASE2Ramucirumab, Merestinib, Cisplatin, Gemcitabine, LY3410738
Tango Therapeutics, Inc.TNGX4PHASE3Ivosidenib
Zymeworks Inc.ZYME1PHASE3Futibatinib, Ivosidenib, Zanidatamab, Trastuzumab, Neratinib
Merck & Co., Inc.MRK2PHASE2pembrolizumab, Sacituzumab tirumotecan, Fluorouracil, Leucovorin or levoleucovorin, Cisplatin
Pfizer Inc.PFE2PHASE2tucatinib, trastuzumab, fulvestrant, oxaliplatin, leucovorin
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2/PHASE3HMPL-453
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
Replimune Group, Inc.REPL1PHASE2RP2, Bevacizumab, Atezolizumab, Durvalumab
Gilead Sciences, Inc.GILD1PHASE2Gemcitabine, Cisplatin, Zimberelimab, Quemliclustat
Incyte CorporationINCY1PHASE2Pemigatinib, Durvalumab
Cogent Biosciences, Inc.COGT1PHASE1CGT4859
Tyra Bioscience, IncTYRA1PHASE1Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Molecular Partners AG Sponsored ADRMOLN1PHASE2MP0317 + Gemcitabine + Cisplatine + Durvalumab, Gemcitabine + Cisplatin + Durvalumab
Context Therapeutics, Inc.CNTX1PHASE1CT-95
MacroGenics, Inc.MGNX1PHASE1MGC028
Summit Therapeutics IncSMMT1PHASE2Ivonescimab, FOLFOX regimen
NextCure, Inc.NXTC1PHASE1LNCB74
Precision BioSciences, Inc.DTIL3PHASE1CEA-targeted CAR-T cells, CEA CAR-T cells
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