Back to resultsA 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).
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Placebo
RG1507
RG1507
erlotinib [Tarceva]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
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.
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.
Sites / Locations
- Tower Cancer Research Foundation
- Florida Cancer Inst.
- Emory Univ Winship Cancer Inst
- University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
- North Shore University Health System
- Joliet Oncology Hematology Associates, Ltd.
- St. Joseph Medical Center
- Massachusetts General Hospital.
- Dana Farber Cancer Inst.
- Beth Israel Deaconess Medical Center
- Hackensack University Medical Center
- Carolina Oncology Specialists, PA - Hickory
- Chattanooga Oncology and Hematology Associates, PC
- Sarah Cannon Research Inst.
- Virginia Cancer Institute
- Flinders Medical Center; Medical Oncology
- Frankston Hospital; Oncology/Haematology
- Sir Charles Gairdner Hospital
- Cliniques Universitaires St-Luc
- GHdC Site Notre Dame
- UZ Antwerpen
- UZ Leuven Gasthuisberg
- Chr de La Citadelle
- Lakeridge Health Oshawa; Oncology
- Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
- Hopital de La Croix Rousse; Service de Pneumologie
- Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
- Hopital Tenon;Pneumologie
- Hopital Larrey; Clinique Des Voies Respiratoires
- Zentralklinik Bad Berka GmbH; Pneumologie
- Helios Klinikum Emil von Behring GmbH
- LungenClinic Großhansdorf GmbH
- Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
- Asklepios Klinik Harburg; Thoraxzentrum
- Thoraxklinik Heidelberg gGmbH
- Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
- Klinikum Leverkusen; Med. Klinik III / Onkologie
- Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
- St. James Hospital; Oncology
- Arcispedale Santa Maria Nuova; Oncologia
- IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
- Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
- Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
- Medical University of Gdansk
- SK Przemienienia Panskiego UM im.K.Marcinkowskiego
- Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
- Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
- Hospital Universitario Puerta de Hierro; Servicio de Oncologia
- Hospital de Cruces; Servicio de Oncologia
- Hospital Clínic i Provincial; Servicio de Hematología y Oncología
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
- Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
- Royal Surrey County Hospital; St. Lukes Cancer Centre
- Wythenshawe Hospital; North West Lung Centre
- Sir Bobby Robson Cancer Research Centre
- New Cross Hospital; Deansley Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo for R1507 (16mg/kg iv)
Placebo for R1507 (9mg/kg iv)
R1507 (16mg/kg iv)
R1507 (9mg/kg iv)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00760929
Brief 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).
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to the termination of the clinical development program.
Study Start Date
November 10, 2008 (Actual)
Primary Completion Date
June 25, 2010 (Actual)
Study Completion Date
June 25, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo for R1507 (16mg/kg iv)
Arm Type
Placebo Comparator
Arm Title
Placebo for R1507 (9mg/kg iv)
Arm Type
Placebo Comparator
Arm Title
R1507 (16mg/kg iv)
Arm Type
Experimental
Arm Title
R1507 (9mg/kg iv)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv 9mg/kg weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv 16mg/kg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
RG1507
Intervention Description
iv 9mg/kg weekly
Intervention Type
Drug
Intervention Name(s)
RG1507
Intervention Description
iv 16mg/kg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150mg oral daily
Primary Outcome Measure Information:
Title
Number of Participants With Progression Free Survival (PFS)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From baseline up to 20 months
Title
Objective Response Rate
Description
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.
Time Frame
From baseline up to 20 months
Title
Duration of Response
Description
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.
Time Frame
From baseline up to 20 months
Title
Time to Response
Description
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).
Time Frame
From baseline up to 20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Florida Cancer Inst.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Emory Univ Winship Cancer Inst
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
North Shore University Health System
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Joliet Oncology Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Inst.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Carolina Oncology Specialists, PA - Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Chattanooga Oncology and Hematology Associates, PC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Research Inst.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Flinders Medical Center; Medical Oncology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Frankston Hospital; Oncology/Haematology
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chr de La Citadelle
City
Liege
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital de La Croix Rousse; Service de Pneumologie
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Tenon;Pneumologie
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Larrey; Clinique Des Voies Respiratoires
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Zentralklinik Bad Berka GmbH; Pneumologie
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Helios Klinikum Emil von Behring GmbH
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Asklepios Klinik Harburg; Thoraxzentrum
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Klinikum Leverkusen; Med. Klinik III / Onkologie
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
St. James Hospital; Oncology
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Arcispedale Santa Maria Nuova; Oncologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
City
Sant'Andrea Delle Fratte (PG)
State/Province
Umbria
ZIP/Postal Code
06132
Country
Italy
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital de Cruces; Servicio de Oncologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Royal Surrey County Hospital; St. Lukes Cancer Centre
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Wythenshawe Hospital; North West Lung Centre
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Sir Bobby Robson Cancer Research Centre
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
New Cross Hospital; Deansley Centre
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
22025157
Citation
Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP, Novello S, Eberhardt WE, Crino L, Habben K, Liu L, Janne PA, Brownstein CM, Reck M. Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol. 2011 Dec 1;29(34):4574-80. doi: 10.1200/JCO.2011.36.6799. Epub 2011 Oct 24.
Results Reference
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Learn more about this trial
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).
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