Study Stopped
The study was terminated due to the termination of the clinical development program.
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).
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
2 other identifiers
interventional
171
11 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedStudy Start
First participant enrolled
November 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2010
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedJanuary 5, 2021
December 1, 2020
1.6 years
September 25, 2008
September 9, 2020
December 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (4)
Overall Survival (OS)
From baseline up to 20 months
Objective Response Rate
From baseline up to 20 months
Duration of Response
From baseline up to 20 months
Time to Response
From baseline up to 20 months
Study Arms (4)
Placebo for R1507 (16mg/kg iv)
PLACEBO COMPARATORPlacebo for R1507 (9mg/kg iv)
PLACEBO COMPARATORR1507 (16mg/kg iv)
EXPERIMENTALR1507 (9mg/kg iv)
EXPERIMENTALInterventions
150mg oral daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Florida Cancer Inst.
New Port Richey, Florida, 34655, United States
Emory Univ Winship Cancer Inst
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
Chicago, Illinois, 60637, United States
North Shore University Health System
Glenview, Illinois, 60026, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Massachusetts General Hospital.
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, 28602, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
Sarah Cannon Research Inst.
Nashville, Tennessee, 37203, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Flinders Medical Center; Medical Oncology
Adelaide, South Australia, 5041, Australia
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, 3199, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Notre Dame
Charleroi, 6000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Chr de La Citadelle
Liège, 3500, Belgium
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9, Canada
Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
La Tronche, 38700, France
Hopital de La Croix Rousse; Service de Pneumologie
Lyon, 69317, France
Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
Paris, 75674, France
Hopital Tenon;Pneumologie
Paris, 75970, France
Hopital Larrey; Clinique Des Voies Respiratoires
Toulouse, 31400, France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, 99437, Germany
Helios Klinikum Emil von Behring GmbH
Berlin, 14165, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle, 06120, Germany
Asklepios Klinik Harburg; Thoraxzentrum
Hamburg, 21075, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
Herne, 44625, Germany
Klinikum Leverkusen; Med. Klinik III / Onkologie
Leverkusen, 51375, Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
München, 80336, Germany
St. James Hospital; Oncology
Dublin, 8, Ireland
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piedmont, 10043, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG), Umbria, 06132, Italy
Medical University of Gdansk
Gdansk, 80-952, Poland
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
Poznan, 60-569, Poland
Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
Szczecin, 70-891, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781, Poland
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, 28222, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, 48903, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, 29010, Spain
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, GU2 7XX, United Kingdom
Wythenshawe Hospital; North West Lung Centre
Manchester, M23 9LT, United Kingdom
Sir Bobby Robson Cancer Research Centre
Newcastle upon Tyne, NE7 7DN, United Kingdom
New Cross Hospital; Deansley Centre
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 22025157DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Development of the study drug R1570 was discontinued based on the available clinical data and the large number of molecules targeting the pathway. Not all efficacy parameters described in the protocol were assessed.
Results Point of Contact
- Title
- Study Director
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
November 10, 2008
Primary Completion
June 25, 2010
Study Completion
June 25, 2010
Last Updated
January 5, 2021
Results First Posted
January 5, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
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).