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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/NCT00760929




Registration number
NCT00760929
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Date last updated
5/01/2021

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
Terminated
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
This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who
failed at least one standard chemotherapy regimen will determine the proportion of patients
with progression-free survival at 12 weeks following combination therapy with R1507 and
Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to
receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks.
Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related
endpoints including overall survival, objective response rate, time to response, time to
progressive disease and duration of response will also be evaluated. The anticipated time on
study treatment is 1-2 years, and the target sample size is <500 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00760929
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00760929