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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00036647




Registration number
NCT00036647
Ethics application status
Date submitted
13/05/2002
Date registered
14/05/2002
Date last updated
10/01/2018

Titles & IDs
Public title
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
BR.21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-small-cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tarceva (erlotinib HCl, OSI-774 )

Treatment: Drugs: Tarceva (erlotinib HCl, OSI-774 )
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2004
Sample size
Target
Accrual to date
Final
731
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital- Australia - Woden
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [4] 0 0
Southern Medical Day Care Center - Wollongong
Recruitment hospital [5] 0 0
Western Hospital - Footscray
Recruitment hospital [6] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - South Australia
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Institute - Victoria
Recruitment hospital [10] 0 0
Austin & Repatriation Medical Centre - Victoria
Recruitment postcode(s) [1] 0 0
2605 - Woden
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2289 - Waratah
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
5000 - South Australia
Recruitment postcode(s) [9] 0 0
3002 - Victoria
Recruitment postcode(s) [10] 0 0
3084 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Washington
Country [3] 0 0
Argentina
State/province [3] 0 0
CP
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Capital Federal
Country [6] 0 0
Brazil
State/province [6] 0 0
Bahia
Country [7] 0 0
Brazil
State/province [7] 0 0
CEP
Country [8] 0 0
Brazil
State/province [8] 0 0
Mg Cep
Country [9] 0 0
Brazil
State/province [9] 0 0
Rs Cep
Country [10] 0 0
Brazil
State/province [10] 0 0
Sp Cep
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Newfoundland and Labrador
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatchewan
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
Country [21] 0 0
China
State/province [21] 0 0
Hong Kong
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Gauting
Country [24] 0 0
Germany
State/province [24] 0 0
Grosshansdorf
Country [25] 0 0
Germany
State/province [25] 0 0
Heidelberg
Country [26] 0 0
Germany
State/province [26] 0 0
Hermer
Country [27] 0 0
Greece
State/province [27] 0 0
Athens
Country [28] 0 0
Israel
State/province [28] 0 0
Afula
Country [29] 0 0
Israel
State/province [29] 0 0
Haifa
Country [30] 0 0
Israel
State/province [30] 0 0
Petach-Tiqva
Country [31] 0 0
Israel
State/province [31] 0 0
Rehovot
Country [32] 0 0
Israel
State/province [32] 0 0
Tel Aviv
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Hashomer
Country [34] 0 0
Israel
State/province [34] 0 0
Zerifin
Country [35] 0 0
Mexico
State/province [35] 0 0
CP
Country [36] 0 0
Mexico
State/province [36] 0 0
Durango
Country [37] 0 0
Mexico
State/province [37] 0 0
Mexico City
Country [38] 0 0
New Zealand
State/province [38] 0 0
Wellington
Country [39] 0 0
New Zealand
State/province [39] 0 0
Auckland 3
Country [40] 0 0
Romania
State/province [40] 0 0
Bucharest
Country [41] 0 0
Romania
State/province [41] 0 0
Cluj-Napoca
Country [42] 0 0
Romania
State/province [42] 0 0
Iasi
Country [43] 0 0
Romania
State/province [43] 0 0
Sibiu
Country [44] 0 0
Singapore
State/province [44] 0 0
Singapore
Country [45] 0 0
South Africa
State/province [45] 0 0
Durban
Country [46] 0 0
South Africa
State/province [46] 0 0
Pretoria
Country [47] 0 0
South Africa
State/province [47] 0 0
Bloemfontein
Country [48] 0 0
South Africa
State/province [48] 0 0
Parklands
Country [49] 0 0
South Africa
State/province [49] 0 0
Parktown
Country [50] 0 0
South Africa
State/province [50] 0 0
Port Elizabeth
Country [51] 0 0
South Africa
State/province [51] 0 0
Rosebank
Country [52] 0 0
Sweden
State/province [52] 0 0
Lund
Country [53] 0 0
Thailand
State/province [53] 0 0
Bangkok
Country [54] 0 0
Thailand
State/province [54] 0 0
Chiangmai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OSI Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Cancer Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00036647
Trial related presentations / 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.
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. doi: 10.1056/NEJMoa050736. Erratum In: N Engl J Med. 2006 Oct 19;355(16):1746.
Public notes

Contacts
Principal investigator
Name 0 0
Frances Shephard, M.D.
Address 0 0
Princess Margaret Hospital, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00036647