LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
- Registration Number
- NCT01523587
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 795
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afatinib afatinib Patients receive afatinib tablets once daily Erlotinib erlotinib Patients receive erlotinib tablets once daily
- Primary Outcome Measures
Name Time Method Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Secondary Outcome Measures
Name Time Method Overall Survival From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.
Number of Participants With Objective Response According to RECIST 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of Participants With Disease Control According to RECIST 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Tumour Shrinkage First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.
A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size.
Post-baseline mean is adjusted for baseline sum of diameters and race.Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
Summary of Time to Deterioration in Coughing, Dyspnoea and Pain. From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.
Change in Score Over Time in Coughing,Dyspnoea and Pain From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.
Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.
The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.
Trial Locations
- Locations (190)
Pulmonology Institute of Veszprem County, Farkasgyepu
🇭🇺Farkasgyepü, Hungary
Sri Ramachandra Medical College & Research Institute
🇮🇳Chennai, India
B. P .Poddar Hospital & Medical Research Ltd.
🇮🇳Kolkata, West Bengal, India
Tata Memorial Hospital
🇮🇳Mumbai, India
Instituto Nacional de Cancerologia
🇲🇽Mexico, Mexico
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
Centro Oncologico Antofagasta
🇨🇱Antofagasta, Chile
Instituto de Terapias Oncologicas Providencia
🇨🇱Providencia, Santiago, Chile
Orlandi Oncologia
🇨🇱Vitacura, Chile
Orchard Healthcare Research Inc
🇺🇸Skokie, Illinois, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Mid Ohio Oncology/Hematology, Inc
🇺🇸Columbus, Ohio, United States
Kimmel Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center of Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Paris Cancer Center (PCC), Texas Oncology
🇺🇸Paris, Texas, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
University General Hospital of Heraklion
🇬🇷Heraklion, Greece
Beijing Hospital
🇨🇳Beijing, China
First Hospital of Jilin University
🇨🇳Changchun, China
Xiangya Hospital, Central South University
🇨🇳Changsha, China
Shanghai Chest Hospital
🇨🇳Shanghai, China
Næstved Sygehus
🇩🇰Næstved, Denmark
HOP de Mulhouse, Onco, Mulhouse
🇫🇷Mulhouse, France
HOP de Rennes, Pneumo, Rennes
🇫🇷Rennes, France
HOP Civil
🇫🇷Strasbourg, France
HOP Foch
🇫🇷Suresnes, France
INS Gustave Roussy
🇫🇷Villejuif, France
Hospital A Coruña
🇪🇸A Coruña, Spain
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Cancer Care of North Florida, PA
🇺🇸Lake City, Florida, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Sutter Medical Group
🇺🇸Sacramento, California, United States
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
West Jefferson General Hospital and Cancer Clinic
🇺🇸Marrero, Louisiana, United States
Commonwealth Hematology-Oncology, PC
🇺🇸Lawrence, Massachusetts, United States
LKH Leoben
🇦🇹Leoben, Austria
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Beijing Cancer Hospital
🇨🇳Beijing, China
INS Jean Godinot, Onco, Reims
🇫🇷Reims, France
HOP Saint Quentin, Onco, Saint Quentin
🇫🇷Saint Quentin, France
Centro Oncologico CAIPO
🇦🇷San Miguel de Tucuman, Argentina
HOP Le Mans
🇫🇷Le Mans, France
the 81th Hospital of PLA
🇨🇳Nanjing, China
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Clínica Colombo S.A.
🇦🇷Cordoba, Argentina
Centro Oncologico de Rosario
🇦🇷Rosario, Argentina
SMZ Baumgartner Hoehe Otto Wagner Spital
🇦🇹Wien, Austria
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
BC Cancer Agency - Fraser Valley Centre
🇨🇦Surrey, British Columbia, Canada
Oncology Hematology Associates of Norhtern Pennsylvania, PC
🇺🇸DuBois, Pennsylvania, United States
AKH d. Stadt Linz, Pulmologie
🇦🇹Linz, Austria
Montreal General Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Instituto Oncologico de Cordoba
🇦🇷Cordoba, Argentina
Centro Internacional de Estudios Clinicos - CIEC
🇨🇱Recoleta, Santiago De Chile, Chile
CTR Oscar Lambret, Cancéro, Lille
🇫🇷Lille, France
HOP de Chauny
🇫🇷Chauny, France
HOP Nord
🇫🇷Marseille Cedex 20, France
INS Bergonié
🇫🇷Bordeaux, France
HOP Gabriel-Montpied
🇫🇷Clermont Ferrand, France
HOP Cochin
🇫🇷Paris, France
HOP Calmette
🇫🇷Lille, France
Herlev Hospital
🇩🇰Herlev, Denmark
Lungenklinik Hemer
🇩🇪Hemer, Germany
HOP de Creteil, Pneumo, Creteil
🇫🇷Creteil, France
HOP Côte de Nacre
🇫🇷Caen, France
INS Paoli-Calmettes
🇫🇷Marseille, France
Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
🇭🇺Deszk, Hungary
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
🇮🇹Bologna, Italy
Universitätsklinikum Mannheim GmbH
🇩🇪Mannheim, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Mathias-Spital Rheine
🇩🇪Rheine, Germany
"Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin
🇬🇷Athens, Greece
General Hospital of Chest Diseases Sotiria
🇬🇷Athens, Greece
Aladar Petz County Teaching Hospital, Dept. Pulmonology
🇭🇺Györ, Hungary
Lung Hospital of Matra, Dept. Pulmonology
🇭🇺Matrahaza, Hungary
Josa Andras Korhaz, Nyiregyhaza
🇭🇺Nyiregyhaza, Hungary
University of Pecs, 1st internal Med. Dept., Pulmonology
🇭🇺Pecs, Hungary
Vikram Hospital
🇮🇳Bangalore, India
V S Hospital
🇮🇳Chennai, India
Dr. Kamakshi Memorial Hospital
🇮🇳Chennai, India
M.S. Patel Cancer Hospital
🇮🇳Karamsad, India
General Hospital of Larissa
🇬🇷Larisa, Greece
Metropolitan Hospital, Oncology Clinic
🇬🇷Neo Faliro, Athens, Greece
Semmelweis University
🇭🇺Budapest, Hungary
CHLN, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
IPO Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Ospedale San Vincenzo
🇮🇹Taormina (ME), Italy
A. O. S. Maria della Misericordia
🇮🇹Udine, Italy
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
St James's Hospital
🇮🇪Dublin 8, Ireland
ASST di Cremona
🇮🇹Cremona, Italy
Spedali Riuniti di Livorno
🇮🇹Livorno, Italy
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Ospedale Molinette, AO Città della Salute e della
🇮🇹Torino, Italy
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital y Clínica OCA S. A. de C. V.
🇲🇽Monterrey, Mexico
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.
🇲🇽Toluca, Mexico
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
The Catholic University of Korea, St.Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Jeroen Bosch Ziekenhuis-Hertogenbosch
🇳🇱's-HERTOGENBOSCH, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
🇳🇱Nieuwegein, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Malaga, Spain
Centro Hospitalar São João,EPE
🇵🇹Porto, Portugal
National Cancer Centre
🇸🇬Singapore, Singapore
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Chang Gung Memorial Hospital Chiayi
🇨🇳Chiayi, Taiwan
Akdeniz Universitesi Tip Fakultesi
🇹🇷Antalya, Turkey
Yedikule Gog. Hst. EAH
🇹🇷Istanbul, Turkey
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
🇹🇷Izmir, Turkey
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
🇨🇳Taoyuan, Taiwan
Hospital La Paz
🇪🇸Madrid, Spain
Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali
🇹🇷Gaziantep, Turkey
China Medical University Hospital
🇨🇳Taichung, Taiwan
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Uludag Universitesi Tip Fakultesi, Bursa
🇹🇷Bursa, Turkey
Dicle Universitesi Tip Fakultesi
🇹🇷Diyarbakir, Turkey
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Maidstone Hospital, Kent Oncology Centre
🇬🇧Maidstone, United Kingdom
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Kartal Egitim Ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Koo Foundation Sun Yet-Sen Cancer Center
🇨🇳Taipei, Taiwan
Taipe Veterans General Hospital
🇨🇳Taipei, Taiwan
Dr.Suat Seren EAH
🇹🇷Izmir, Turkey
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, United Kingdom
Scarborough Hospital
🇬🇧Scarborough, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Blue Ridge Cancer Care
🇺🇸Christiansburg, Virginia, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
Cancer Therapy and Research at UTHSCSA
🇺🇸San Antonio, Texas, United States
University of California
🇺🇸La Jolla, California, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Boca Raton Reginl Hospital-Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Instituto Medico Especializado Alexander Fleming
🇦🇷Ciudad Autonoma de Bs As, Argentina
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
HOP d'Angers
🇫🇷Angers, France
Odense Universitetshospital
🇩🇰Odense C, Denmark
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
National Koranyi TBC and Pulm. Internal Med. Clinic
🇭🇺Budapest, Hungary
Pest County Lung Hospital, Department No. 3
🇭🇺Törökbalint, Hungary
University Hospital of Larisa, Oncology Clinic
🇬🇷Larisa, Greece
General Hospital "G. Papageorgiou"
🇬🇷Thessaloniki, Greece
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
🇳🇱Maastricht, Netherlands
IPO Lisboa Francisco Gentil, EPE
🇵🇹Lisboa, Portugal
Johns Hopkins Singapore International Medical Centre
🇸🇬Singapore, Singapore
Buddhist Tzu Chi General Hospital
🇨🇳Chiayi, Taiwan
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
Queens Medical Associates
🇺🇸Fresh Meadows, New York, United States
Klinikum Esslingen GmbH
🇩🇪Esslingen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
University of Louisville
🇺🇸Louisville, Kentucky, United States
HOP Val de Grâce, Onco, Paris
🇫🇷Paris, France
Ruby Hall Clinic
🇮🇳Pune, India
Montefiore Medical Center
🇺🇸Bronx, New York, United States