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Gefitinib or Docetaxel

Phase 3

Non-Small Cell Lung Cancer | Small molecule | Oncology |AstraZeneca PLC|Trials Updated: Dec 18, 2007

Gefitinib or Docetaxel development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2005

Gefitinib or Docetaxel target and mechanism

Molecular targetEGFR
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL939

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment484

FDA Designations

No designations recorded

Gefitinib or Docetaxel clinical trials

Gefitinib or Docetaxel · 1 trial · 1 indication

Phase 3 1
NCT00252707Iressa 2nd Line Phase III Study in JapanNon-Small Cell Lung Cancer
COMPLETED484 Analytics
PHASE3COMPLETED
Iressa 2nd Line Phase III Study in Japan
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the overall survival with these treatments as the primary outcome.

Secondary Endpoints

Determine the followings as the secondary outcome variables:
- Progression-free survival (PFS)
- Time to treatment failure (TTF)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Gefitinib or DocetaxelDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC * You have been treated with chemotherapy including platinums for NSCLC. Exclusion Criteria: * You have received treatment for non-small lung cancer within 4 weeks before your partici...

Countries:Japan
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Competitive Landscape -Non-Small Cell Lung Cancer 544 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.ABBV12PHASE3Telisotuzumab vedotin, ABBV-1480, Livmoniplimab, Budigalimab, Telisotuzumab Adizutecan
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
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS11PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, KFA115
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
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
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Frequently asked questions about Gefitinib or Docetaxel

What is gefitinib used for in non-small cell lung cancer?

Gefitinib is an oral small molecule developed by AstraZeneca PLC (ticker AZN) for non-small cell lung cancer. It is being studied in a Phase 3 second-line setting in Japan. Gefitinib is an investigational therapy in this program and is not described as approved for this use.

What does gefitinib target?

Gefitinib targets EGFR, the epidermal growth factor receptor. It acts as an EGFR inhibitor, a small molecule that blocks EGFR signaling. This mechanism underlies its development in non-small cell lung cancer, where EGFR-driven tumor growth is relevant to treatment.

Who makes gefitinib?

Gefitinib is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the Phase 3 program in non-small cell lung cancer, including the Japanese second-line study of gefitinib.

What phase is gefitinib in for non-small cell lung cancer?

Gefitinib is in Phase 3 development for non-small cell lung cancer. The program includes one completed Phase 3 trial with 484 enrolled patients. Gefitinib is investigational in this setting and is not described as approved for this indication.

What clinical trials is gefitinib in for non-small cell lung cancer?

Gefitinib has been studied in NCT00252707, titled Iressa 2nd Line Phase III Study in Japan. This completed Phase 3 trial enrolled 484 patients with non-small cell lung cancer in Japan. It was randomized, was not double blind, and used an uncontrolled design.

Is gefitinib the same as docetaxel?

No. Gefitinib and docetaxel are different drugs. Gefitinib is an EGFR inhibitor small molecule developed by AstraZeneca PLC for non-small cell lung cancer. Docetaxel is a separate agent. The two names refer to distinct therapies and should not be used interchangeably.