OSI-774 (Tarceva) in Treating Patients With Stage III or NCT00036647

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00036647
Other study ID #	BR.21
Secondary ID
Status	Completed
Phase	Phase 3
First received	May 13, 2002
Last updated	January 8, 2018
Start date	November 1, 2001
Est. completion date	January 30, 2004

Study information
Verified date	June 2015
Source	Astellas Pharma Inc
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Other known NCT identifiers

NCT00026325

Recruitment information / eligibility
Status	Completed
Enrollment	731
Est. completion date	January 30, 2004
Est. primary completion date	January 30, 2004
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	- Clinical diagnosis of stage IIIB or IV non-small cell lung cancer. - Must have evidence of disease (clinical or radiological). - Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days. - If the patient has had surgery, the surgery was at least 2 weeks ago. - Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms. - If the patient received radiation therapy, treatment was at least 4 weeks ago.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tarceva (erlotinib HCl, OSI-774 )

Locations
Country	Name	City	State
Argentina	Centro Medico Confidence	Buenos Aires	CP
Argentina	Hospital Britanico	Buenos Aires
Argentina	Hospital Churruca Visca	Buenos Aires
Argentina	Hospital Interzonal de Agudos Evita	Buenos Aires
Argentina	Instituto Alexander fleming	Buenos Aires
Argentina	Hospital Italiano	Capital Federal
Argentina	Instituto Oncologico Angel Roffo	Capital Federal
Australia	Western Hospital	Footscray	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Royal Adelaide Hospital	South Australia
Australia	Austin & Repatriation Medical Centre	Victoria
Australia	Peter MacCallum Cancer Institute	Victoria
Australia	Newcastle Mater Misericordiae Hospital	Waratah	New South Wales
Australia	Canberra Hospital- Australia	Woden	Australian Capital Territory
Australia	Southern Medical Day Care Center	Wollongong	New South Wales
Brazil	Hospital Vera Cruz S/A	Belo Horizonte	Mg Cep
Brazil	Instituto do Cancer do Ceara	Fortaleza	CEP
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	Rs Cep
Brazil	Irmandade Santa Casa de Miseicordia de Porto	Porto Alegre	Rs Cep
Brazil	Instituto Nacional de Cancerologia	Rio De Janeiro	CEP
Brazil	Nucleo de Oncologia da Bahia	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC	Santo Andre	Sp Cep
Brazil	Escola Paulista de Medicina	Sao Paulo	Sp Cep
Brazil	Instituto do Cancer Arnaldo Vieira de Carvalho	Sao Paulo	SP
Canada	The Royal Victoria Hospital	Barrie	Ontario
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Cancer Centre for the Southern Interior	Kelowna	British Columbia
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Credit Valley Hospital	Missisauga	Ontario
Canada	Hopital Du Sacre - Coeur De Montreal	Montreal	Quebec
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Peterborough Regional Health Centre	Peterborough	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Group Health Centre	Sault Saint Marie	Ontario
Canada	Hotel Dieu Health Sciences Hospital	St. Catherines	Ontario
Canada	Dr.H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Toronto-Sunnybrook Reg.Canc.Center	Toronto	Ontario
Canada	BCCA - Vancouver Island	Victoria	British Columbia
Canada	Humbar River Regional Hospital	Weston	Ontario
Canada	CancerCare Manitoba (CCMB)	Winnipeg	Manitoba
Chile	Institution: Clinica Las Condes	Santiago
China	Pamela Youde Nethersole Easter Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
Germany	Lungenklinik Heckeshorn	Berlin
Germany	Asklepios Fachkiniken	Gauting
Germany	Zentrum fur pheulmologie und Thoraxchirurgie	Grosshansdorf
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Lungenklinik Hermer	Hermer
Greece	Sotiria Hospital	Athens
Israel	Haemek Medical Center	Afula
Israel	RAMBAM Medical Center	Haifa
Israel	Rabin Medical Center Beilinson Campus	Petach-Tiqva
Israel	Rabin Medical Center Golda Campus	Petach-Tiqva
Israel	Kaplan Medical Center	Rehovot
Israel	Sourasky Medical Center Oncology Institute	Tel Aviv
Israel	Sheba Medical Center Oncology Day Care	Tel Hashomer
Israel	Assaf Harofeh Medical Center	Zerifin
Mexico	Centro Estatal de Cancerologia de Durango	Durango
Mexico	Hospital Central Sur de Alta Especialidad, PEMEX	Mexico City
Mexico	Instituto Nacional de Cancerologia	Mexico City	CP
New Zealand	Greenlane Hospital - New Zealand	Auckland 3
New Zealand	Wellington Hospital	Riddiford Street	Wellington
Romania	Oncology Institute Bucharest	Bucharest
Romania	Oncology Institute Ion Chiricuta	Cluj-Napoca
Romania	Spitalul Universitar	Iasi
Romania	Clinical County Hospital	Sibiu
Singapore	National Cancer Centre - Singapore	Singapore
Singapore	National University Hospital	Singapore
South Africa	Oncotherapy Dept, National Hospital	Bloemfontein
South Africa	Die Wilgers Hospital	Lynnwood	Pretoria
South Africa	Sandton Oncology Centre	Parklands
South Africa	Johannesburg Hospital	Parktown
South Africa	Eastern Cape Oncology Centre	Port Elizabeth
South Africa	Mary Potter Oncology Centre	Pretoria
South Africa	University of Pretoria	Pretoria
South Africa	Rosebank Clinic Oncology Unit	Rosebank
South Africa	Durban Oncology Centre	Westbridge	Durban
Sweden	Lund University Hospital	Lund
Sweden	Sahlgrenska University Hospital	Lund
Thailand	Div. of Med Onc. The National Cancer Institute of Thailand	Bangkok
Thailand	Chiangmai University	Chiangmai
Thailand	Pramongkutklao Hospital	Phayathai	Bangkok
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Washington	Seattle	Washington

Sponsors *(2)*
Lead Sponsor	Collaborator
OSI Pharmaceuticals	Canadian Cancer Trials Group

Countries where clinical trial is conducted

United States, Argentina, Australia, Brazil, Canada, Chile, China, Germany, Greece, Israel, Mexico, New Zealand, Romania, Singapore, South Africa, Sweden, Thailand,

References & Publications (2)

Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabárbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. — View Citation

Tsao MS, Sakurada A, Cutz JC, Zhu CQ, Kamel-Reid S, Squire J, Lorimer I, Zhang T, Liu N, Daneshmand M, Marrano P, da Cunha Santos G, Lagarde A, Richardson F, Seymour L, Whitehead M, Ding K, Pater J, Shepherd FA. Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med. 2005 Jul 14;353(2):133-44. Erratum in: N Engl J Med. 2006 Oct 19;355(16):1746. — View Citation

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Active, not recruiting	`NCT04487080` - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer	Phase 3
Not yet recruiting	`NCT04255836` - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)	Phase 2
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Suspended	`NCT05421936` - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed	`NCT02847377` - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC	N/A
Completed	`NCT04427072` - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation	Phase 3
Recruiting	`NCT04823377` - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.	N/A

External Links

Link to results on Astellas Clinical Study Results website

OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

Study information