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
LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
2 other identifiers
interventional
795
23 countries
192
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2012
Longer than P75 for phase_3
192 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
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2013
CompletedResults Posted
Study results publicly available
November 21, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2017
CompletedFebruary 15, 2019
February 1, 2019
1.6 years
January 30, 2012
October 6, 2014
February 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
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.
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
Secondary Outcomes (7)
Overall Survival
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
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).
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).
Tumour Shrinkage
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
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).
- +2 more secondary outcomes
Study Arms (2)
Afatinib
EXPERIMENTALPatients receive afatinib tablets once daily
Erlotinib
ACTIVE COMPARATORPatients receive erlotinib tablets once daily
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of advanced stage NSCLC squamous histology.
- Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC.
- Eligible to receive 2nd line therapy in the opinion of the investigator.
- Measurable disease according to RECIST 1.1.
- Adequate Performance Status.
- Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable.
- Adequate organ function.
- Age = 18 years and above.
- Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.
You may not qualify if:
- Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies.
- Radiotherapy within 4 weeks prior to randomization.
- Active brain metastases .
- Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer).
- Known pre-existing interstitial lung disease.
- Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom
- Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
- Female patients of childbearing potential (see Section 4.2.3.3) who:
- are nursing or
- are pregnant or
- are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by this protocol.
- Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
- Known or suspected active drug or alcohol abuse in the opinion of the investigator.
- Any contraindications for therapy with afatinib or erlotinib.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (192)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
University of California
La Jolla, California, 92093, United States
Sutter Medical Group
Sacramento, California, 95816, United States
Boca Raton Reginl Hospital-Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Memorial Healthcare System
Hollywood, Florida, 22021, United States
Cancer Care of North Florida, PA
Lake City, Florida, 32024, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Orchard Healthcare Research Inc
Skokie, Illinois, 60076, United States
University of Louisville
Louisville, Kentucky, 40202, United States
West Jefferson General Hospital and Cancer Clinic
Marrero, Louisiana, 70072, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Commonwealth Hematology-Oncology, PC
Lawrence, Massachusetts, 01841, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Queens Medical Associates
Fresh Meadows, New York, 11366, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43201, United States
Mid Ohio Oncology/Hematology, Inc
Columbus, Ohio, 43219, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Oncology Hematology Associates of Norhtern Pennsylvania, PC
DuBois, Pennsylvania, 15801, United States
Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
Temple University Cancer Center
Philadelphia, Pennsylvania, 19140, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Cancer Center of Cookeville Regional Medical Center
Cookeville, Tennessee, 38501, United States
Paris Cancer Center (PCC), Texas Oncology
Paris, Texas, 75460, United States
Cancer Therapy and Research at UTHSCSA
San Antonio, Texas, 78229, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Blue Ridge Cancer Care
Christiansburg, Virginia, 24382, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma de Bs As, C1426ANZ, Argentina
Instituto Oncologico de Cordoba
Córdoba, X5000HXL, Argentina
Clínica Colombo S.A.
Córdoba, X5002AOQ, Argentina
Centro Oncologico de Rosario
Rosario, S2000KZE, Argentina
Centro Oncologico CAIPO
San Miguel de Tucumán, T4000GTB, Argentina
Medical University of Innsbruck
Innsbruck, 6020, Austria
LKH Leoben
Leoben, 8700, Austria
AKH d. Stadt Linz, Pulmologie
Linz, 4020, Austria
SMZ Baumgartner Hoehe Otto Wagner Spital
Vienna, 1140, Austria
BC Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, V3V 1Z2, Canada
Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Centro Oncologico Antofagasta
Antofagasta, 1720421, Chile
Instituto de Terapias Oncologicas Providencia
Providencia, Santiago, 7501088, Chile
Centro Internacional de Estudios Clinicos - CIEC
Recoleta, Santiago de Chile, 8420383, Chile
Orlandi Oncologia
Vitacura, 7630457, Chile
Beijing Cancer Hospital
Beijing, 100036, China
Beijing Hospital
Beijing, 100730, China
First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital, Central South University
Changsha, 410008, China
Sun Yat-Sen University Cancer Center
Guangzhou, 510060, China
the 81th Hospital of PLA
Nanjing, 210002, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Shanghai Chest Hospital
Shanghai, 200030, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Herlev Hospital
Herlev, 2730, Denmark
Næstved Sygehus
Næstved, 4700, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
HOP d'Angers
Angers, 49 933, France
INS Bergonié
Bordeaux, 33076, France
HOP Côte de Nacre
Caen, 14033, France
HOP de Chauny
Chauny, 02303, France
HOP Gabriel-Montpied
Clermont-Ferrand, 63003, France
HOP de Creteil, Pneumo, Creteil
Créteil, 94010, France
HOP Le Mans
Le Mans, 72037, France
CTR Oscar Lambret, Cancéro, Lille
Lille, 59020, France
HOP Calmette
Lille, 59037, France
INS Paoli-Calmettes
Marseille, 13273, France
HOP Nord
Marseille, 13915, France
HOP de Mulhouse, Onco, Mulhouse
Mulhouse, 68070, France
HOP Cochin
Paris, 75014, France
HOP Val de Grâce, Onco, Paris
Paris, 75230, France
INS Jean Godinot, Onco, Reims
Reims, 51056, France
HOP de Rennes, Pneumo, Rennes
Rennes, 35033, France
HOP Saint Quentin, Onco, Saint Quentin
Saint-Quentin, 02321, France
HOP Civil
Strasbourg, 67091, France
HOP Foch
Suresnes, 92151, France
INS Gustave Roussy
Villejuif, 94805, France
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45147, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Mathias-Spital Rheine
Rheine, 48431, Germany
"Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin
Athens, 11527, Greece
General Hospital of Chest Diseases Sotiria
Athens, 11527, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
University Hospital of Larisa, Oncology Clinic
Larissa, 41110, Greece
General Hospital of Larissa
Larissa, 41221, Greece
Metropolitan Hospital, Oncology Clinic
Neo Faliro, Athens, 18547, Greece
General Hospital "G. Papageorgiou"
Thessaloniki, 56429, Greece
National Koranyi TBC and Pulm. Internal Med. Clinic
Budapest, 1121, Hungary
Semmelweis University
Budapest, 1125, Hungary
Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
Deszk, 6772, Hungary
Pulmonology Institute of Veszprem County, Farkasgyepu
Farkasgyepü, 8582, Hungary
Aladar Petz County Teaching Hospital, Dept. Pulmonology
Győr, 9023, Hungary
Lung Hospital of Matra, Dept. Pulmonology
Mátraháza, 3233, Hungary
Josa Andras Korhaz, Nyiregyhaza
Nyíregyháza, 4400, Hungary
University of Pecs, 1st internal Med. Dept., Pulmonology
Pécs, 7623, Hungary
Pest County Lung Hospital, Department No. 3
Törökbálint, 2045, Hungary
Vikram Hospital
Bangalore, 560052, India
V S Hospital
Chennai, 600031, India
Dr. Kamakshi Memorial Hospital
Chennai, 600100, India
Sri Ramachandra Medical College & Research Institute
Chennai, 600116, India
M.S. Patel Cancer Hospital
Karamsad, 388325, India
B. P .Poddar Hospital & Medical Research Ltd.
Kolkata, West Bengal, 700053, India
Tata Memorial Hospital
Mumbai, 400012, India
Ruby Hall Clinic
Pune, 411001, India
St James's Hospital
Dublin, Dublin, Ireland
P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
Bologna, 40139, Italy
ASST di Cremona
Cremona, 26100, Italy
Spedali Riuniti di Livorno
Livorno, 57100, Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, 80131, Italy
Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Azienda Ospedaliera di Parma
Parma, 43100, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Ospedale San Vincenzo
Taormina (ME), 98039, Italy
Ospedale Molinette, AO Città della Salute e della
Torino, 10126, Italy
A. O. S. Maria della Misericordia
Udine, 33100, Italy
Instituto Nacional de Cancerologia
México, 14080, Mexico
Hospital y Clínica OCA S. A. de C. V.
Monterrey, 64000, Mexico
Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.
Toluca, 50080, Mexico
Jeroen Bosch Ziekenhuis-Hertogenbosch
's-Hertogenbosch, 5223 GZ, Netherlands
Rijnstate Hospital
Arnhem, 6815 AD, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
Maastricht, 6229 HX, Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CD, Netherlands
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3041-801, Portugal
CHLN, EPE - Hospital de Santa Maria
Lisbon, 1064-035, Portugal
IPO Lisboa Francisco Gentil, EPE
Lisbon, 1099-023, Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Centro Hospitalar São João,EPE
Porto, 4200-319, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4434-502, Portugal
National Cancer Centre
Singapore, 169610, Singapore
Johns Hopkins Singapore International Medical Centre
Singapore, 308433, Singapore
Chungbuk National University Hospital
Cheongju-si, 361-711, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Gyeongsang National University Hospital
Jinju, 660-702, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 130-710, South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 137-701, South Korea
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 442-723, South Korea
Ulsan University Hospital
Ulsan, 682-714, South Korea
Hospital A Coruña
A Coruña, 15006, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clínico de Valencia
Valencia, 46010, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Chang Gung Memorial Hospital Chiayi
Chiayi City, 613, Taiwan
Buddhist Tzu Chi General Hospital
Chiayi City, 622, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Koo Foundation Sun Yet-Sen Cancer Center
Taipei, 112, Taiwan
Taipe Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan District, 330, Taiwan
Akdeniz Universitesi Tip Fakultesi
Antalya, 07070, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi, Bursa
Bursa, 16045, Turkey (Türkiye)
Dicle Universitesi Tip Fakultesi
Diyarbakır, Turkey (Türkiye)
Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali
Gaziantep, 27310, Turkey (Türkiye)
Kartal Egitim Ve Arastirma Hastanesi
Istanbul, Turkey (Türkiye)
Yedikule Gog. Hst. EAH
Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
Izmir, 35100, Turkey (Türkiye)
Dr.Suat Seren EAH
Izmir, 35120, Turkey (Türkiye)
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Harrogate District Hospital
Harrogate, HG2 7SX, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
The Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Maidstone Hospital, Kent Oncology Centre
Maidstone, ME16 9QQ, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Scarborough Hospital
Scarborough, YO12 6QL, United Kingdom
The Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (4)
Lu S, Li W, Zhou C, Hu CP, Qin S, Cheng G, Feng J, Wang J, Cseh A, Peil B, Gibson N, Ehrnrooth E, Zhang L. Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung. Onco Targets Ther. 2018 Nov 30;11:8565-8573. doi: 10.2147/OTT.S161506. eCollection 2018.
PMID: 30573970DERIVEDGoss GD, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Goker E, Georgoulias V, Li W, Guclu S, Isla D, Min YJ, Morabito A, Ardizzoni A, Gadgeel SM, Fulop A, Buhnemann C, Gibson N, Kramer N, Solca F, Cseh A, Ehrnrooth E, Soria JC. Association of ERBB Mutations With Clinical Outcomes of Afatinib- or Erlotinib-Treated Patients With Lung Squamous Cell Carcinoma: Secondary Analysis of the LUX-Lung 8 Randomized Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1189-1197. doi: 10.1001/jamaoncol.2018.0775.
PMID: 29902295DERIVEDGadgeel S, Goss G, Soria JC, Felip E, Georgoulias V, Lu S, Cobo M, Syrigos K, Lee KH, Goker E, Guclu SZ, Isla D, Morabito A, Dupuis N, Buhnemann C, Kramer N, Solca F, Ehrnrooth E, Ardizzoni A. Evaluation of the VeriStrat(R) serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study. Lung Cancer. 2017 Jul;109:101-108. doi: 10.1016/j.lungcan.2017.05.010. Epub 2017 May 11.
PMID: 28577938DERIVEDSoria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Goker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. doi: 10.1016/S1470-2045(15)00006-6. Epub 2015 Jul 5.
PMID: 26156651DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 1, 2012
Study Start
March 5, 2012
Primary Completion
October 21, 2013
Study Completion
December 27, 2017
Last Updated
February 15, 2019
Results First Posted
November 21, 2014
Record last verified: 2019-02