Clinical trial NCT00760929: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 171
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 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.


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.

Primary outcomes:
measure: Number of Participants With Progression Free Survival (PFS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From baseline up to 20 months
measure: Objective Response Rate
timeFrame: From baseline up to 20 months
measure: Duration of Response
timeFrame: From baseline up to 20 months
measure: Time to Response
timeFrame: From baseline up to 20 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: New Port Richey
country: United States
facility: Florida Cancer Inst.
state: Florida
city: Atlanta
country: United States
facility: Emory Univ Winship Cancer Inst
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
state: Illinois
city: Glenview
country: United States
facility: North Shore University Health System
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates, Ltd.
state: Illinois
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Inst.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA - Hickory
state: North Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Inst.
state: Tennessee
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Adelaide
country: Australia
facility: Flinders Medical Center; Medical Oncology
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital; Oncology/Haematology
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: Chr de La Citadelle
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa; Oncology
state: Ontario
city: La Tronche
country: France
facility: Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
city: Lyon
country: France
facility: Hopital de La Croix Rousse; Service de Pneumologie
city: Paris
country: France
facility: Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
city: Paris
country: France
facility: Hopital Tenon;Pneumologie
city: Toulouse
country: France
facility: Hopital Larrey; Clinique Des Voies Respiratoires
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH; Pneumologie
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring GmbH
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg; Thoraxzentrum
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Herne
country: Germany
facility: Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen; Med. Klinik III / Onkologie
city: Muenchen
country: Germany
facility: Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
city: Dublin
country: Ireland
facility: St. James Hospital; Oncology
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Oncologia
state: Emilia-Romagna
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Orbassano
country: Italy
facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
state: Piemonte
city: Sant'Andrea Delle Fratte (PG)
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
state: Umbria
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Poznan
country: Poland
facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
state: Madrid
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital; St. Lukes Cancer Centre
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital; North West Lung Centre
city: Newcastle Upon Tyne
country: United Kingdom
facility: Sir Bobby Robson Cancer Research Centre
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital; Deansley Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.