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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00531960




Registration number
NCT00531960
Ethics application status
Date submitted
18/09/2007
Date registered
19/09/2007
Date last updated
11/11/2014

Titles & IDs
Public title
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
Scientific title
A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer
Secondary ID [1] 0 0
BO20571
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Erlotinib
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Standard platinum-based chemotherapy

Active Comparator: Bevacizumab, Chemotherapy - Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.

Experimental: Bevacizumab, Erlotinib - Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.


Treatment: Drugs: Erlotinib
150 mg, PO, daily

Treatment: Drugs: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7

Treatment: Drugs: Standard platinum-based chemotherapy
At the discretion of the investigator

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Disease Progression or Death - Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.
Timepoint [1] 0 0
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Primary outcome [2] 0 0
PFS - The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.
Timepoint [2] 0 0
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Secondary outcome [1] 0 0
Percentage of Participants Who Died - Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.
Timepoint [1] 0 0
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Secondary outcome [2] 0 0
OS - The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.
Timepoint [2] 0 0
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Secondary outcome [3] 0 0
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0 - BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
Timepoint [3] 0 0
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Secondary outcome [4] 0 0
Percentage of Participants With Disease Control According to RECIST V 1.0 - Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
Timepoint [4] 0 0
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- advanced (stage IIIb and IV) non-small cell lung cancer;

- measurable disease;

- ECOG PS 0-1.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- prior chemotherapy or treatment with another systemic anti-cancer agent;

- radiotherapy within 4 weeks prior to first dose of study treatment;

- CNS metastases;

- other malignancies in past 5 years, except for adequately treated cancer in situ of
the cervix, basal or squamous cell skin cancer.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
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)
VIC
Recruitment hospital [1] 0 0
- East Bentleigh
Recruitment hospital [2] 0 0
- Geelong
Recruitment postcode(s) [1] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
France
State/province [2] 0 0
Bayonne
Country [3] 0 0
France
State/province [3] 0 0
Dijon
Country [4] 0 0
France
State/province [4] 0 0
Le Mans
Country [5] 0 0
France
State/province [5] 0 0
Marseille
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Strasbourg
Country [8] 0 0
France
State/province [8] 0 0
Vandoeuvre-les-nancy
Country [9] 0 0
Italy
State/province [9] 0 0
Friuli-Venezia Giulia
Country [10] 0 0
Italy
State/province [10] 0 0
Lombardia
Country [11] 0 0
Italy
State/province [11] 0 0
Marche
Country [12] 0 0
Italy
State/province [12] 0 0
Toscana
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Bundang City
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Daegu
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Gyeonggi-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Incheon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Suwon
Country [19] 0 0
Lithuania
State/province [19] 0 0
Kaunas
Country [20] 0 0
Lithuania
State/province [20] 0 0
Vilnius
Country [21] 0 0
Netherlands
State/province [21] 0 0
's Hertogenbosch
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Eindhoven
Country [24] 0 0
Netherlands
State/province [24] 0 0
Groningen
Country [25] 0 0
Netherlands
State/province [25] 0 0
Heerlen
Country [26] 0 0
Netherlands
State/province [26] 0 0
Maastricht
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
Poland
State/province [28] 0 0
Lodz
Country [29] 0 0
Poland
State/province [29] 0 0
Lublin
Country [30] 0 0
Poland
State/province [30] 0 0
Otwock
Country [31] 0 0
Romania
State/province [31] 0 0
Bucuresti
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj Napoca
Country [33] 0 0
Romania
State/province [33] 0 0
Timisoara
Country [34] 0 0
Singapore
State/province [34] 0 0
Singapore
Country [35] 0 0
Spain
State/province [35] 0 0
Alicante
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
La Coruña
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Malaga
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Taiwan
State/province [41] 0 0
Changhua
Country [42] 0 0
Taiwan
State/province [42] 0 0
Kaohsiung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Dudley
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Guildford
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and
chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small
cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus
Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus
Avastin. The anticipated time on study treatment is until disease progression, and the target
sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00531960
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
Other publications