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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
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
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
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
Sex
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
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
124
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/study/NCT00531960
Trial related presentations / publications
Ciuleanu T, Tsai CM, Tsao CJ, Milanowski J, Amoroso D, Heo DS, Groen HJ, Szczesna A, Chung CY, Chao TY, Middleton G, Zeaiter A, Klingelschmitt G, Klughammer B, Thatcher N. A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Lung Cancer. 2013 Nov;82(2):276-81. doi: 10.1016/j.lungcan.2013.08.002. Epub 2013 Aug 13.
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/study/NCT00531960