Clinical trial NCT00531960: A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced (stage IIIb and IV) non-small cell lung cancer;
* measurable disease;
* ECOG PS 0-1.

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.

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: 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.
measure: PFS
timeFrame: 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 outcomes:
measure: Percentage of Participants Who Died
timeFrame: 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.
measure: OS
timeFrame: 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.
measure: Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
timeFrame: 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.
measure: Percentage of Participants With Disease Control According to RECIST V 1.0
timeFrame: 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
Other outcomes:
Locations:
city: East Bentleigh
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Leuven
country: Belgium
city: Bayonne
country: France
city: Dijon
country: France
city: Le Mans
country: France
city: Marseille
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Vandoeuvre-les-nancy
country: France
city: Aviano
country: Italy
state: Friuli-Venezia Giulia
city: Milano
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Bundang City
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: 's Hertogenbosch
country: Netherlands
city: Amsterdam
country: Netherlands
city: Eindhoven
country: Netherlands
city: Groningen
country: Netherlands
city: Heerlen
country: Netherlands
city: Maastricht
country: Netherlands
city: Rotterdam
country: Netherlands
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Otwock
country: Poland
city: Bucuresti
country: Romania
city: Cluj Napoca
country: Romania
city: Timisoara
country: Romania
city: Singapore
country: Singapore
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: La Coruña
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Dudley
country: United Kingdom
city: Guildford
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.