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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: afatinib; Drug: erlotinib

• Study Type: Interventional
• Enrollment (Actual): 795
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Bs As, Argentina, C1426ANZ
    • Instituto Medico Especializado Alexander Fleming
  • Cordoba, Argentina, X5000HXL
    • Instituto Oncologico de Cordoba
  • Cordoba, Argentina, X5002AOQ
    • Clínica Colombo S.A.
  • Rosario, Argentina, S2000KZE
    • Centro Oncologico de Rosario
  • San Miguel de Tucuman, Argentina, T4000GTB
    • Centro Oncologico CAIPO
• Austria
  • Innsbruck, Austria, 6020
    • Medical University of Innsbruck
  • Leoben, Austria, 8700
    • LKH Leoben
  • Linz, Austria, 4020
    • AKH d. Stadt Linz, Pulmologie
  • Wien, Austria, 1140
    • SMZ Baumgartner Hoehe Otto Wagner Spital
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer Agency - Fraser Valley Centre
  • Ontario
    • Kingston, Ontario, Canada, K7L 5P9
      • Kingston General Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital - McGill University Health Centre
• Chile
  • Antofagasta, Chile, 1720421
    • Centro Oncologico Antofagasta
  • Providencia, Santiago, Chile, 7501088
    • Instituto de Terapias Oncologicas Providencia
  • Recoleta, Santiago De Chile, Chile, 8420383
    • Centro Internacional de Estudios Clinicos - CIEC
  • Vitacura, Chile, 7630457
    • Orlandi Oncologia
• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100036
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • First Hospital of Jilin University
  • Changsha, China, 410008
    • Xiangya Hospital, Central South University
  • Guangzhou, China, 510060
    • Sun Yat-sen University Cancer Center
  • Nanjing, China, 210009
    • Jiangsu Cancer Hospital
  • Nanjing, China, 210002
    • the 81th Hospital of PLA
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Næstved, Denmark, 4700
    • Næstved Sygehus
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• France
  • Angers, France, 49 933
    • HOP d'Angers
  • Bordeaux, France, 33076
    • INS Bergonie
  • Caen, France, 14033
    • HOP Côte de Nacre
  • Chauny, France, 02303
    • HOP de Chauny
  • Clermont Ferrand, France, 63003
    • HOP Gabriel-Montpied
  • Creteil, France, 94010
    • HOP de Creteil, Pneumo, Creteil
  • Le Mans, France, 72037
    • HOP Le Mans
  • Lille, France, 59037
    • HOP Calmette
  • Lille, France, 59020
    • CTR Oscar Lambret, Cancéro, Lille
  • Marseille, France, 13273
    • INS Paoli-Calmettes
  • Marseille Cedex 20, France, 13915
    • HOP Nord
  • Mulhouse, France, 68070
    • HOP de Mulhouse, Onco, Mulhouse
  • Paris, France, 75014
    • HOP Cochin
  • Paris, France, 75230
    • HOP Val de Grâce, Onco, Paris
  • Reims, France, 51056
    • INS Jean Godinot, Onco, Reims
  • Rennes, France, 35033
    • HOP de Rennes, Pneumo, Rennes
  • Saint Quentin, France, 02321
    • HOP Saint Quentin, Onco, Saint Quentin
  • Strasbourg, France, 67091
    • HOP Civil
  • Suresnes, France, 92151
    • HOP Foch
  • Villejuif, France, 94805
    • INS Gustave Roussy
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Essen, Germany, 45147
    • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Esslingen, Germany, 73730
    • Klinikum Esslingen GmbH
  • Frankfurt am Main, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Freiburg, Germany, 79106
    • Universitatsklinikum Freiburg
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim GmbH
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Rheine, Germany, 48431
    • Mathias-Spital Rheine
• Greece
  • Athens, Greece, 11527
    • "Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases Sotiria
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion
  • Larisa, Greece, 41110
    • University Hospital of Larisa, Oncology Clinic
  • Larisa, Greece, 41221
    • General Hospital of Larissa
  • Neo Faliro, Athens, Greece, 18547
    • Metropolitan Hospital, Oncology Clinic
  • Thessaloniki, Greece, 56429
    • General Hospital "G. Papageorgiou"
• Hungary
  • Budapest, Hungary, 1121
    • National Koranyi TBC and Pulm. Internal Med. Clinic
  • Budapest, Hungary, 1125
    • Semmelweis University
  • Deszk, Hungary, 6772
    • Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
  • Farkasgyepü, Hungary, 8582
    • Pulmonology Institute of Veszprem County, Farkasgyepu
  • Györ, Hungary, 9023
    • Aladar Petz County Teaching Hospital, Dept. Pulmonology
  • Matrahaza, Hungary, 3233
    • Lung Hospital of Matra, Dept. Pulmonology
  • Nyiregyhaza, Hungary, 4400
    • Josa Andras Korhaz, Nyiregyhaza
  • Pecs, Hungary, 7623
    • University of Pecs, 1st internal Med. Dept., Pulmonology
  • Törökbalint, Hungary, 2045
    • Pest County Lung Hospital, Department No. 3
• India
  • Bangalore, India, 560052
    • Vikram Hospital
  • Chennai, India, 600031
    • V S Hospital
  • Chennai, India, 600100
    • Dr. Kamakshi Memorial Hospital
  • Chennai, India, 600116
    • Sri Ramachandra MedicaL College & Research Institute
  • Karamsad, India, 388325
    • M.S. Patel Cancer Hospital
  • Kolkata, West Bengal, India, 700053
    • B. P .Poddar Hospital & Medical Research Ltd.
  • Mumbai, India, 400012
    • Tata Memorial Hospital
  • Pune, India, 411001
    • Ruby Hall Clinic
• Ireland
  • Dublin 8, Ireland, Dublin
    • St James's Hospital
• Italy
  • Bologna, Italy, 40139
    • P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
  • Cremona, Italy, 26100
    • Asst Di Cremona
  • Livorno, Italy, 57100
    • Spedali Riuniti di Livorno
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Fondazione Pascale
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Parma, Italy, 43100
    • Azienda Ospedaliera Di Parma
  • Pisa, Italy, 56126
    • Azienda Ospedaliera Universitaria Pisana
  • Rozzano (MI), Italy, 20089
    • Istituto Clinico Humanitas
  • Taormina (ME), Italy, 98039
    • Ospedale San Vincenzo
  • Torino, Italy, 10126
    • Ospedale Molinette, AO Città della Salute e della
  • Udine, Italy, 33100
    • A. O. S. Maria della Misericordia
• Korea, Republic of
  • Cheongju, Korea, Republic of, 361-711
    • Chungbuk National University Hospital
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Medical Center
  • Jinju, Korea, Republic of, 660-702
    • Gyeongsang National University Hospital
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 130-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Suwon, Korea, Republic of, 442-723
    • The Catholic University of Korea, St.Vincent's Hospital
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital
• Mexico
  • Mexico, Mexico, 14080
    • Instituto Nacional de Cancerologia
  • Monterrey, Mexico, 64000
    • Hospital y Clínica OCA S. A. de C. V.
  • Toluca, Mexico, 50080
    • Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.
• Netherlands
  • 's-HERTOGENBOSCH, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis-Hertogenbosch
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Hospital
  • Breda, Netherlands, 4818 CK
    • Amphia ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Maastricht, Netherlands, 6229 HX
    • METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis, locatie Nieuwegein
  • Rotterdam, Netherlands, 3015 CD
    • Erasmus Medisch Centrum
• Portugal
  • Coimbra, Portugal, 3041-801
    • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • Lisboa, Portugal, 1099-023
    • IPO Lisboa Francisco Gentil, EPE
  • Lisboa, Portugal, 1064-035
    • CHLN, EPE - Hospital de Santa Maria
  • Porto, Portugal, 4200-319
    • Centro Hospitalar São João,EPE
  • Porto, Portugal, 4200-072
    • IPO Porto Francisco Gentil, EPE
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre
  • Singapore, Singapore, 308433
    • Johns Hopkins Singapore International Medical Centre
• Spain
  • A Coruña, Spain, 15006
    • Hospital A Coruña
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clínico Universitario Lozano Blesa
• Taiwan
  • Chiayi, Taiwan, 613
    • Chang Gung Memorial Hospital Chiayi
  • Chiayi, Taiwan, 622
    • Buddhist Tzu Chi General Hospital
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Taipe Veterans General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yet-Sen Cancer Center
  • Taoyuan, Taiwan, 330
    • Chang Gung Memorial Hospital(TaoYuan)
• Turkey
  • Antalya, Turkey, 07070
    • Akdeniz Universitesi Tip Fakultesi
  • Bursa, Turkey, 16045
    • Uludag Universitesi Tip Fakultesi, Bursa
  • Diyarbakir, Turkey
    • Dicle Universitesi Tip Fakultesi
  • Gaziantep, Turkey, 27310
    • Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali
  • Istanbul, Turkey
    • Kartal Egitim Ve Arastirma Hastanesi
  • Istanbul, Turkey
    • Yedikule Gog. Hst. EAH
  • Izmir, Turkey, 35120
    • Dr.Suat Seren EAH
  • Izmir, Turkey, 35100
    • Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West Of Scotland Cancer Centre
  • Harrogate, United Kingdom, HG2 7SX
    • Harrogate District Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Hospital
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital, Kent Oncology Centre
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Scarborough, United Kingdom, YO12 6QL
    • Scarborough Hospital
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer and Research Centers
  • California
    • La Jolla, California, United States, 92093
      • University of California
    • Sacramento, California, United States, 95816
      • Sutter Medical Group
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Reginl Hospital-Lynn Cancer Institute
    • Hollywood, Florida, United States, 22021
      • Memorial Healthcare System
    • Lake City, Florida, United States, 32024
      • Cancer Care of North Florida, PA
  • Illinois
    • Niles, Illinois, United States, 60714
      • Illinois Cancer Specialists
    • Skokie, Illinois, United States, 60076
      • Orchard Healthcare Research Inc
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • West Jefferson General Hospital and Cancer Clinic
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
    • Lawrence, Massachusetts, United States, 01841
      • Commonwealth Hematology-Oncology, PC
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Fresh Meadows, New York, United States, 11366
      • Queens Medical Associates
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43201
      • The Ohio State University Wexner Medical Center
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology/Hematology, Inc
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Oncology Hematology Associates of Norhtern Pennsylvania, PC
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Kimmel Cancer Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Cookeville, Tennessee, United States, 38501
      • Cancer Center of Cookeville Regional Medical Center
  • Texas
    • Paris, Texas, United States, 75460
      • Paris Cancer Center (PCC), Texas Oncology
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Research at UTHSCSA
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Virginia
    • Christiansburg, Virginia, United States, 24382
      • Blue Ridge Cancer Care
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Diagnosis of advanced stage NSCLC squamous histology.
2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC.
3. Eligible to receive 2nd line therapy in the opinion of the investigator.
4. Measurable disease according to RECIST 1.1.
5. Adequate Performance Status.
6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable.
7. Adequate organ function.
8. Age = 18 years and above.
9. Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.

Exclusion criteria:

1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies.
2. Radiotherapy within 4 weeks prior to randomization.
3. Active brain metastases .
4. 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).
5. Known pre-existing interstitial lung disease.
6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom
7. 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.
8. 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.

9. Female patients of childbearing potential (see Section 4.2.3.3) who:

   1. are nursing or
   2. are pregnant or
   3. 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.
10. 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.
11. Known or suspected active drug or alcohol abuse in the opinion of the investigator.
12. Any contraindications for therapy with afatinib or erlotinib.
13. Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs.
14. Major surgery within 4 weeks of starting study treatment.
15. Prior participation in an afatinib clinical study, even if not assigned to afatinib.
16. Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product).
17. Patients without Progression of their lung cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afatinib; Patients receive afatinib tablets once daily	Drug: afatinib; Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
Active Comparator: Erlotinib; Patients receive erlotinib tablets once daily	Drug: erlotinib; erlotinib taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.	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	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.	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	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.	First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
Tumour Shrinkage	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.	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	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.	From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.	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.	From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
Change in Score Over Time in Coughing,Dyspnoea and Pain	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.	From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.
• Goss 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.
• Gadgeel 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.
• Soria 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2012
• Primary Completion (Actual): October 21, 2013
• Study Completion (Actual): December 27, 2017

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Afatinib
• Other Study ID Numbers: 1200.125; 2011-002380-24 (EudraCT Number)