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).
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00760929
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 171
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R1507 (16mg/kg iv) RG1507 - Placebo for R1507 (16mg/kg iv) Placebo - Placebo for R1507 (16mg/kg iv) erlotinib [Tarceva] - Placebo for R1507 (9mg/kg iv) Placebo - Placebo for R1507 (9mg/kg iv) erlotinib [Tarceva] - R1507 (16mg/kg iv) erlotinib [Tarceva] - R1507 (9mg/kg iv) RG1507 - R1507 (9mg/kg iv) erlotinib [Tarceva] -
- Primary Outcome Measures
Name Time Method Number of Participants With Progression Free Survival (PFS) 12 weeks 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
Name Time Method Overall Survival (OS) From baseline up to 20 months 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 From baseline up to 20 months 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 to Response From baseline up to 20 months 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).
Duration of Response From baseline up to 20 months 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.
Trial Locations
- Locations (57)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Lakeridge Health Oshawa; Oncology
🇨🇦Oshawa, Ontario, Canada
North Shore University Health System
🇺🇸Glenview, Illinois, United States
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
🇺🇸Chicago, Illinois, United States
St. James Hospital; Oncology
🇮🇪Dublin, Ireland
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
🇵🇱Poznan, Poland
Florida Cancer Inst.
🇺🇸New Port Richey, Florida, United States
Hospital de Cruces; Servicio de Oncologia
🇪🇸Bilbao, Vizcaya, Spain
LungenClinic Großhansdorf GmbH
🇩🇪Großhansdorf, Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
🇩🇪Muenchen, Germany
Sir Bobby Robson Cancer Research Centre
🇬🇧Newcastle Upon Tyne, United Kingdom
Emory Univ Winship Cancer Inst
🇺🇸Atlanta, Georgia, United States
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
🇩🇪Herne, Germany
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Medical University of Gdansk
🇵🇱Gdansk, Poland
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
Joliet Oncology Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
🇪🇸Majadahonda, Madrid, Spain
Royal Surrey County Hospital; St. Lukes Cancer Centre
🇬🇧Guildford, United Kingdom
Chr de La Citadelle
🇧🇪Liege, Belgium
Arcispedale Santa Maria Nuova; Oncologia
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Wythenshawe Hospital; North West Lung Centre
🇬🇧Manchester, United Kingdom
Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
🇵🇱Szczecin, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
🇵🇱Warszawa, Poland
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
🇮🇹Genova, Liguria, Italy
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
🇪🇸Barcelona, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
🇪🇸Malaga, Spain
New Cross Hospital; Deansley Centre
🇬🇧Wolverhampton, United Kingdom
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
🇮🇹Orbassano, Piemonte, Italy
Klinikum Leverkusen; Med. Klinik III / Onkologie
🇩🇪Leverkusen, Germany
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
🇪🇸Barcelona, Spain
Dana Farber Cancer Inst.
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
GHdC Site Notre Dame
🇧🇪Charleroi, Belgium
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
🇮🇹Sant'Andrea Delle Fratte (PG), Umbria, Italy
Hopital Tenon;Pneumologie
🇫🇷Paris, France
Hopital Larrey; Clinique Des Voies Respiratoires
🇫🇷Toulouse, France
Sarah Cannon Research Inst.
🇺🇸Nashville, Tennessee, United States
Massachusetts General Hospital.
🇺🇸Boston, Massachusetts, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Carolina Oncology Specialists, PA - Hickory
🇺🇸Hickory, North Carolina, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Chattanooga Oncology and Hematology Associates, PC
🇺🇸Chattanooga, Tennessee, United States
Flinders Medical Center; Medical Oncology
🇦🇺Adelaide, South Australia, Australia
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Frankston Hospital; Oncology/Haematology
🇦🇺Frankston, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
UZ Antwerpen
🇧🇪Edegem, Belgium
Hopital de La Croix Rousse; Service de Pneumologie
🇫🇷Lyon, France
Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
🇫🇷Paris, France
Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
🇫🇷La Tronche, France
Zentralklinik Bad Berka GmbH; Pneumologie
🇩🇪Bad Berka, Germany
Helios Klinikum Emil von Behring GmbH
🇩🇪Berlin, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
🇩🇪Halle (Saale), Germany
Asklepios Klinik Harburg; Thoraxzentrum
🇩🇪Hamburg, Germany
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
🇮🇹Milano, Lombardia, Italy