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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00760929




Registration number
NCT00760929
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008

Titles & IDs
Public title
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
Scientific title
A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy
Secondary ID [1] 0 0
2008-001736-12
Secondary ID [2] 0 0
NO21160
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 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 - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - RG1507
Treatment: Drugs - RG1507
Treatment: Drugs - erlotinib [Tarceva]

Placebo comparator: Placebo for R1507 (16mg/kg iv) -

Placebo comparator: Placebo for R1507 (9mg/kg iv) -

Experimental: R1507 (16mg/kg iv) -

Experimental: R1507 (9mg/kg iv) -


Treatment: Drugs: Placebo
iv 9mg/kg weekly

Treatment: Drugs: Placebo
iv 16mg/kg every 3 weeks

Treatment: Drugs: RG1507
iv 9mg/kg weekly

Treatment: Drugs: RG1507
iv 16mg/kg every 3 weeks

Treatment: Drugs: erlotinib [Tarceva]
150mg oral daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Progression Free Survival (PFS)
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From baseline up to 20 months
Secondary outcome [2] 0 0
Objective Response Rate
Timepoint [2] 0 0
From baseline up to 20 months
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
From baseline up to 20 months
Secondary outcome [4] 0 0
Time to Response
Timepoint [4] 0 0
From baseline up to 20 months

Eligibility
Key inclusion criteria
* male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
* patients must have failed at least one but no more than two standard chemotherapy regimens;
* measurable disease according to the RECIST criteria;
* Eastern Cooperative Oncology Group (ECOG) performance status;
* life expectancy >12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* patients with active central nervous system (CNS) lesions;
* prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (EGFR) targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/06/2010
Sample size
Target
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Flinders Medical Center; Medical Oncology - Adelaide
Recruitment hospital [2] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
5041 - Adelaide
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Charleroi
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
France
State/province [17] 0 0
La Tronche
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Toulouse
Country [21] 0 0
Germany
State/province [21] 0 0
Bad Berka
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Großhansdorf
Country [24] 0 0
Germany
State/province [24] 0 0
Halle (Saale)
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Germany
State/province [26] 0 0
Heidelberg
Country [27] 0 0
Germany
State/province [27] 0 0
Herne
Country [28] 0 0
Germany
State/province [28] 0 0
Leverkusen
Country [29] 0 0
Germany
State/province [29] 0 0
Muenchen
Country [30] 0 0
Ireland
State/province [30] 0 0
Dublin
Country [31] 0 0
Italy
State/province [31] 0 0
Emilia-Romagna
Country [32] 0 0
Italy
State/province [32] 0 0
Liguria
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Piemonte
Country [35] 0 0
Italy
State/province [35] 0 0
Umbria
Country [36] 0 0
Poland
State/province [36] 0 0
Gdansk
Country [37] 0 0
Poland
State/province [37] 0 0
Poznan
Country [38] 0 0
Poland
State/province [38] 0 0
Szczecin
Country [39] 0 0
Poland
State/province [39] 0 0
Warszawa
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Vizcaya
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Malaga
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Guildford
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle Upon Tyne
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00760929