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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants who had not died or progressed at the time of the final analysis were censored at the date of last contact.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Overall Survival (OS) - OS was defined as the median time, in weeks, from the date of randomization to the date of death, due to any cause. Participants who have not died at the time of the final analysis will be censored at the date the participant was last known to be alive. The 90% CI was estimated using Kaplan-Meier methodology.
Timepoint [1] 0 0
From baseline up to 20 months
Secondary outcome [2] 0 0
Objective Response Rate - Objective response rate (ORR) was defined by RECIST criteria as the best response achieved by a patient over the course of the trial, which includes a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation, stable disease (SD), or progressive disease (PD). PR was defined as = 30% decrease in sum of longest diameter of all target lesions, from baseline sum. CR was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. PD = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.
Timepoint [2] 0 0
From baseline up to 20 months
Secondary outcome [3] 0 0
Duration of Response - Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
Timepoint [3] 0 0
From baseline up to 20 months
Secondary outcome [4] 0 0
Time to Response - This is defined for participants with objective response, as the date of randomization to the date of first CR or PR which will be the date the response is first radiographically documented following initiation of therapy (the date of the actual imaging modality).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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/show/NCT00760929