Carcinoma, Non-small-cell LungPhase 3NCT00036647
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 3 study testing Tarceva (erlotinib HCl, OSI-774 ) in people with Carcinoma, Non-small-cell Lung, run by OSI Pharmaceuticals at 97 sites in 17 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small-cell Lung
- What is being tested?
- Tarceva (erlotinib HCl, OSI-774 )
- How many people
- 731 participants
- Where
- 97 sitesin 17 countries
- Study dates
- 1 Nov 2001to 30 Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
97 sites in 17 countries.
97 sites in 17 countries
Canada27 sites
The Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Hamilton Regional Cancer Centre
Hamilton, Ontario, L9V 5C2
Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Credit Valley Hospital
Missisauga, Ontario, L5M 2N1
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
McGill University
Montreal, Quebec, H2W 1S6
Hopital Du Sacre - Coeur De Montreal
Montreal, Quebec, H4J 1C5
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Peterborough Regional Health Centre
Peterborough, Ontario, K9H 7B6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Hotel Dieu Health Sciences Hospital
Saint Catherines, Ontario, L2R 5K3
Group Health Centre
Sault Saint Marie, Ontario, P6A 2C4
Dr.H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Hopital Laval
Ste-Foy, Quebec, G1V 4G5
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Toronto-Sunnybrook Reg.Canc.Center
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Island
Victoria, British Columbia, V8R 6V5
Humbar River Regional Hospital
Weston, Ontario, M9N 1N8
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, R3E 0V9
Australia10 sites
Western Hospital
Footscray, Victoria, 3011
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Prince of Wales Hospital
Randwick, New South Wales, 2031
Royal Adelaide Hospital
South Australia, 5000
Peter MacCallum Cancer Institute
Victoria, 3002
Austin & Repatriation Medical Centre
Victoria, 3084
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2289
Canberra Hospital- Australia
Woden, Australian Capital Territory, 2605
Southern Medical Day Care Center
Wollongong, New South Wales, 2500
Brazil9 sites
Hospital Vera Cruz S/A
Belo Horizonte, MG CEP, 30190-130
Instituto do Cancer do Ceara
Fortaleza, CEP, 60430-230
Irmandade Santa Casa de Miseicordia de Porto
Porto Alegre, RS CEP, 90020-090
Hospital Sao Lucas da PUCRS
Porto Alegre, RS CEP, 90610-000
Instituto Nacional de Cancerologia
Rio de Janeiro, CEP, 20230-130
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-070
Faculdade de Medicina do ABC
Santo André, SP CEP, 09060-650
Escola Paulista de Medicina
São Paulo, SP CEP, 040039-032
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, São Paulo, 01224-010
South Africa9 sites
Oncotherapy Dept, National Hospital
Bloemfontein, 9301
Die Wilgers Hospital
Lynnwood, Pretoria
Sandton Oncology Centre
Parklands, 2121
Johannesburg Hospital
Parktown, 2193
Eastern Cape Oncology Centre
Port Elizabeth, 6000
Mary Potter Oncology Centre
Pretoria
University of Pretoria
Pretoria
Rosebank Clinic Oncology Unit
Rosebank
Durban Oncology Centre
Westbridge, Durban, 4091
Israel8 sites
Haemek Medical Center
Afula, 18101
RAMBAM Medical Center
Haifa
Rabin Medical Center Beilinson Campus
Petach-Tiqva, 49100
Rabin Medical Center Golda Campus
Petach-Tiqva, 49372
Kaplan Medical Center
Rehovot
Sourasky Medical Center Oncology Institute
Tel Aviv, 64239
Sheba Medical Center Oncology Day Care
Tel HaShomer, 52621
Assaf Harofeh Medical Center
Tsrifin, 70300
Argentina7 sites
Centro Medico Confidence
Buenos Aires, CP, 1642
Hospital Britanico
Buenos Aires, 1280
Hospital Interzonal de Agudos Evita
Buenos Aires, B1824
Instituto Alexander fleming
Buenos Aires, C1426ANZ
Hospital Churruca Visca
Buenos Aires, C1427
Instituto Oncologico Angel Roffo
Capital Federal, CP1417
Hospital Italiano
Capital Federal
Germany5 sites
Lungenklinik Heckeshorn
Berlin, 14109
Asklepios Fachkiniken
Gauting, 82131
Zentrum fur pheulmologie und Thoraxchirurgie
Großhansdorf, 22927
Thoraxklinik Heidelberg
Heidelberg, 69126
Lungenklinik Hermer
Hermer, 58675
Romania4 sites
Oncology Institute Bucharest
Bucharest
Oncology Institute Ion Chiricuta
Cluj-Napoca, 3400
Spitalul Universitar
Iași, 6600
Clinical County Hospital
Sibiu, 2400
Mexico3 sites
Centro Estatal de Cancerologia de Durango
Durango
Instituto Nacional de Cancerologia
Mexico City, CP, 14000
Hospital Central Sur de Alta Especialidad, PEMEX
Mexico City
Thailand3 sites
Div. of Med Onc. The National Cancer Institute of Thailand
Bangkok, 10400
Chiangmai University
Chiang Mai, 50002
Pramongkutklao Hospital
Phayathai, Bangkok, 10400
United States2 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Washington
Seattle, Washington, 98109
China2 sites
Pamela Youde Nethersole Easter Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
New Zealand2 sites
Greenlane Hospital - New Zealand
Auckland
Wellington Hospital
Riddiford Street, Wellington Region
Singapore2 sites
National University Hospital
Singapore, 119074
National Cancer Centre - Singapore
Singapore, 169610
Sweden2 sites
Lund University Hospital
Lund
Sahlgrenska University Hospital
Lund
About this study
Official title: A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
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).
- Conditions
- Carcinoma, Non-small-cell Lung
- Being tested
- Tarceva (erlotinib HCl, OSI-774 )
- Keywords
- Non-Small Cell Lung Cancer, Tarceva, EGFR, erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tarceva (erlotinib HCl, OSI-774 )Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2002 (estimated)
- Study start1 Nov 2001
- Primary completion30 Jan 2004
- Study completion30 Jan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-small-cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Canadian Cancer Trials Group
- Investigators
- Frances Shephard, M.D., Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036647
- Sponsor's protocol ID
- BR.21
- Status last verified
- Jun 2015
- First submitted
- 13 May 2002
- Last updated
- 10 Jan 2018
- Results posted
- No
Publications
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, Santabarbara 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. doi: 10.1056/NEJMoa050753.
PubMed 16014882Tsao 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. doi: 10.1056/NEJMoa050736.
PubMed 16014883
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
- ClinicalTrials.gov ID
- NCT00036647
- Acronym / sponsor ID
- BR.21
- Conditions
- Carcinoma, Non-small-cell Lung
- Keywords
- Non-Small Cell Lung Cancer, Tarceva, EGFR, erlotinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Canadian Cancer Trials Group
- Study start
- 1 Nov 2001 (actual)
- Primary completion
- 30 Jan 2004 (actual)
- Study completion
- 30 Jan 2004 (actual)
- First posted
- 14 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tarceva (erlotinib HCl, OSI-774 ) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 16014882Shepherd 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, Santabarbara 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. doi: 10.1056/NEJMoa050753.
- Background: PubMed 16014883Tsao 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. doi: 10.1056/NEJMoa050736.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Shephard, M.D. principal investigator
Princess Margaret Hospital, Canada
97 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tarceva (erlotinib HCl, OSI-774 ) in people with Carcinoma, Non-small-cell Lung, run by OSI Pharmaceuticals at 97 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in Canada, Australia, Brazil, South Africa, Israel and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00036647, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.