search
Back to results

A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erlotinib
Bevacizumab
Standard platinum-based chemotherapy
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bevacizumab, Chemotherapy

Bevacizumab, Erlotinib

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 18, 2007
Last Updated
November 4, 2014
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00531960
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab, Chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bevacizumab, Erlotinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg, PO, daily
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Intervention Type
Drug
Intervention Name(s)
Standard platinum-based chemotherapy
Intervention Description
At the discretion of the investigator
Primary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression or Death
Description
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.
Time Frame
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.
Title
PFS
Description
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.
Time Frame
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 Measure Information:
Title
Percentage of Participants Who Died
Description
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.
Time Frame
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.
Title
OS
Description
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.
Time Frame
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.
Title
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
Description
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.
Time Frame
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.
Title
Percentage of Participants With Disease Control According to RECIST V 1.0
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
VIC 3165
Country
Australia
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Bayonne
ZIP/Postal Code
64100
Country
France
City
Dijon
ZIP/Postal Code
21079
Country
France
City
Le Mans
ZIP/Postal Code
72037
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
City
Ancona
State/Province
Marche
ZIP/Postal Code
60121
Country
Italy
City
Lido Di Camaiore
State/Province
Toscana
ZIP/Postal Code
55043
Country
Italy
City
Bundang City
ZIP/Postal Code
463-802
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
411-769
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-807
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
City
's Hertogenbosch
ZIP/Postal Code
5211 RW
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
City
Lodz
ZIP/Postal Code
91-520
Country
Poland
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
City
Timisoara
ZIP/Postal Code
1900
Country
Romania
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Alicante
ZIP/Postal Code
3010
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
City
Taipei
Country
Taiwan
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23992877
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.
Results Reference
derived

Learn more about this trial

A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

We'll reach out to this number within 24 hrs