AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT01523587

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

A Phase 3 study testing afatinib and erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 192 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
afatinib and erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
795 participants
Where
192 sitesin 23 countries
Study dates
5 Mar 2012to 27 Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs.
  • Major surgery within 4 weeks of starting study treatment.
  • Prior participation in an afatinib clinical study, even if not assigned to afatinib.
  • 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).
  • Patients without Progression of their lung cancer.

Trial locations and contacts

192 sites in 23 countries.

192 sites in 23 countries

United States33 sites

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Boca Raton Reginl Hospital-Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Blue Ridge Cancer Care

    Christiansburg, Virginia, 24382

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201

  • Mid Ohio Oncology/Hematology, Inc

    Columbus, Ohio, 43219

  • Cancer Center of Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Oncology Hematology Associates of Norhtern Pennsylvania, PC

    DuBois, Pennsylvania, 15801

  • Queens Medical Associates

    Fresh Meadows, New York, 11366

  • Memorial Healthcare System

    Hollywood, Florida, 22021

  • University of California

    La Jolla, California, 92093

  • Cancer Care of North Florida, PA

    Lake City, Florida, 32024

  • Commonwealth Hematology-Oncology, PC

    Lawrence, Massachusetts, 01841

  • University of Louisville

    Louisville, Kentucky, 40202

  • West Jefferson General Hospital and Cancer Clinic

    Marrero, Louisiana, 70072

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Paris Cancer Center (PCC), Texas Oncology

    Paris, Texas, 75460

  • Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Temple University Cancer Center

    Philadelphia, Pennsylvania, 19140

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Sutter Medical Group

    Sacramento, California, 95816

  • Cancer Therapy and Research at UTHSCSA

    San Antonio, Texas, 78229

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60076

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

France20 sites

  • HOP d'Angers

    Angers, 49 933

  • INS Bergonié

    Bordeaux, 33076

  • HOP Côte de Nacre

    Caen, 14033

  • HOP de Chauny

    Chauny, 02303

  • HOP Gabriel-Montpied

    Clermont-Ferrand, 63003

  • HOP de Creteil, Pneumo, Creteil

    Créteil, 94010

  • HOP Le Mans

    Le Mans, 72037

  • CTR Oscar Lambret, Cancéro, Lille

    Lille, 59020

  • HOP Calmette

    Lille, 59037

  • INS Paoli-Calmettes

    Marseille, 13273

  • HOP Nord

    Marseille, 13915

  • HOP de Mulhouse, Onco, Mulhouse

    Mulhouse, 68070

  • HOP Cochin

    Paris, 75014

  • HOP Val de Grâce, Onco, Paris

    Paris, 75230

  • INS Jean Godinot, Onco, Reims

    Reims, 51056

  • HOP de Rennes, Pneumo, Rennes

    Rennes, 35033

  • HOP Saint Quentin, Onco, Saint Quentin

    Saint-Quentin, 02321

  • HOP Civil

    Strasbourg, 67091

  • HOP Foch

    Suresnes, 92151

  • INS Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy11 sites

  • P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

    Bologna, 40139

  • ASST di Cremona

    Cremona, 26100

  • Spedali Riuniti di Livorno

    Livorno, 57100

  • Istituto Nazionale Tumori Fondazione Pascale

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliera di Parma

    Parma, 43100

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Ospedale San Vincenzo

    Taormina (ME), 98039

  • Ospedale Molinette, AO Città della Salute e della

    Torino, 10126

  • A. O. S. Maria della Misericordia

    Udine, 33100

Other trials in Italy

Germany10 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45147

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Lungenklinik Hemer

    Hemer, 58675

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

  • Universitätsklinikum Münster

    Münster, 48149

  • Mathias-Spital Rheine

    Rheine, 48431

Other trials in Germany

United Kingdom10 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Harrogate District Hospital

    Harrogate, HG2 7SX

  • Royal Free Hospital

    London, NW3 2QG

  • The Royal Marsden Hospital

    London, SW3 6JJ

  • Maidstone Hospital, Kent Oncology Centre

    Maidstone, ME16 9QQ

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Scarborough Hospital

    Scarborough, YO12 6QL

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

China9 sites

  • Beijing Cancer Hospital

    Beijing, 100036

  • Beijing Hospital

    Beijing, 100730

  • First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital, Central South University

    Changsha, 410008

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • the 81th Hospital of PLA

    Nanjing, 210002

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

Other trials in China

Hungary9 sites

  • National Koranyi TBC and Pulm. Internal Med. Clinic

    Budapest, 1121

  • Semmelweis University

    Budapest, 1125

  • Institute of Chest Diseases Csongrad County,Dpt. Pulmonology

    Deszk, 6772

  • Pulmonology Institute of Veszprem County, Farkasgyepu

    Farkasgyepü, 8582

  • Aladar Petz County Teaching Hospital, Dept. Pulmonology

    Győr, 9023

  • Lung Hospital of Matra, Dept. Pulmonology

    Mátraháza, 3233

  • Josa Andras Korhaz, Nyiregyhaza

    Nyíregyháza, 4400

  • University of Pecs, 1st internal Med. Dept., Pulmonology

    Pécs, 7623

  • Pest County Lung Hospital, Department No. 3

    Törökbálint, 2045

Other trials in Hungary

South Korea9 sites

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Gyeongsang National University Hospital

    Jinju, 660-702

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 130-710

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 137-701

  • The Catholic University of Korea, St.Vincent's Hospital

    Suwon, 442-723

  • Ulsan University Hospital

    Ulsan, 682-714

Other trials in South Korea

Spain9 sites

  • Hospital A Coruña

    A Coruña, 15006

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico de Valencia

    Valencia, 46010

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Taiwan9 sites

  • Chang Gung Memorial Hospital Chiayi

    Chiayi City, 613

  • Buddhist Tzu Chi General Hospital

    Chiayi City, 622

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 100

  • Koo Foundation Sun Yet-Sen Cancer Center

    Taipei, 112

  • Taipe Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital(TaoYuan)

    Taoyuan, 330

Other trials in Taiwan

India8 sites

  • Vikram Hospital

    Bangalore, 560052

  • V S Hospital

    Chennai, 600031

  • Dr. Kamakshi Memorial Hospital

    Chennai, 600100

  • Sri Ramachandra Medical College & Research Institute

    Chennai, 600116

  • M.S. Patel Cancer Hospital

    Karamsad, 388325

  • B. P .Poddar Hospital & Medical Research Ltd.

    Kolkata, West Bengal, 700053

  • Tata Memorial Hospital

    Mumbai, 400012

  • Ruby Hall Clinic

    Pune, 411001

Other trials in India

Turkey (Türkiye)8 sites

  • Akdeniz Universitesi Tip Fakultesi

    Antalya, 07070

  • Uludag Universitesi Tip Fakultesi, Bursa

    Bursa, 16045

  • Dicle Universitesi Tip Fakultesi

    Diyarbakır

  • Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali

    Gaziantep, 27310

  • Kartal Egitim Ve Arastirma Hastanesi

    Istanbul

  • Yedikule Gog. Hst. EAH

    Istanbul

  • Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

    Izmir, 35100

  • Dr.Suat Seren EAH

    Izmir, 35120

Other trials in Turkey (Türkiye)

Greece7 sites

  • "Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin

    Athens, 11527

  • General Hospital of Chest Diseases Sotiria

    Athens, 11527

  • University General Hospital of Heraklion

    Heraklion, 71110

  • University Hospital of Larisa, Oncology Clinic

    Larissa, 41110

  • General Hospital of Larissa

    Larissa, 41221

  • Metropolitan Hospital, Oncology Clinic

    Neo Faliro, Athens, 18547

  • General Hospital "G. Papageorgiou"

    Thessaloniki, 56429

Other trials in Greece

Netherlands7 sites

  • Jeroen Bosch Ziekenhuis-Hertogenbosch

    's-Hertogenbosch, 5223 GZ

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

    Maastricht, 6229 HX

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CD

Other trials in Netherlands

Portugal6 sites

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3041-801

  • CHLN, EPE - Hospital de Santa Maria

    Lisbon, 1064-035

  • IPO Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • IPO Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar São João,EPE

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Argentina5 sites

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma de Bs As, C1426ANZ

  • Instituto Oncologico de Cordoba

    Córdoba, X5000HXL

  • Clínica Colombo S.A.

    Córdoba, X5002AOQ

  • Centro Oncologico de Rosario

    Rosario, S2000KZE

  • Centro Oncologico CAIPO

    San Miguel de Tucumán, T4000GTB

Other trials in Argentina

Canada5 sites

  • Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • BC Cancer Agency - Fraser Valley Centre

    Surrey, British Columbia, V3V 1Z2

Other trials in Canada

Austria4 sites

  • Medical University of Innsbruck

    Innsbruck, 6020

  • LKH Leoben

    Leoben, 8700

  • AKH d. Stadt Linz, Pulmologie

    Linz, 4020

  • SMZ Baumgartner Hoehe Otto Wagner Spital

    Vienna, 1140

Other trials in Austria

Chile4 sites

  • Centro Oncologico Antofagasta

    Antofagasta, 1720421

  • Instituto de Terapias Oncologicas Providencia

    Providencia, Santiago, 7501088

  • Centro Internacional de Estudios Clinicos - CIEC

    Recoleta, Santiago de Chile, 8420383

  • Orlandi Oncologia

    Vitacura, 7630457

Other trials in Chile

Denmark3 sites

  • Herlev Hospital

    Herlev, 2730

  • Næstved Sygehus

    Næstved, 4700

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Mexico3 sites

  • Instituto Nacional de Cancerologia

    México, 14080

  • Hospital y Clínica OCA S. A. de C. V.

    Monterrey, 64000

  • Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.

    Toluca, 50080

Other trials in Mexico

Singapore2 sites

  • National Cancer Centre

    Singapore, 169610

  • Johns Hopkins Singapore International Medical Centre

    Singapore, 308433

Other trials in Singapore

Ireland1 site

  • St James's Hospital

    Dublin, Dublin

Other trials in Ireland

About this study

Official title: 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.

Being tested
afatinib, erlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • afatinibDrug

    Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.

  • erlotinibDrug

    erlotinib taken once daily

Study groups in NCT01523587
Study groupRoleWhat they receive
AfatinibExperimentalPatients receive afatinib tablets once daily
Receives: Drug: afatinib
ErlotinibActive comparatorPatients receive erlotinib tablets once daily
Receives: Drug: erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

Secondary outcomes (7)

  1. Overall Survival

    Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.

    Measured: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

  2. 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.

    Measured: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

  3. 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.

    Measured: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

  4. 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.

    Measured: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

  5. 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.

    Measured: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

  6. 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.

    Measured: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

  7. 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.

    Measured: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2012 (estimated)
  2. Study start5 Mar 2012
  3. Primary completion21 Oct 2013
  4. Study completion27 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
795 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01523587
Sponsor's protocol ID
1200.125
Other IDs
2011-002380-24
Status last verified
Feb 2019
First submitted
30 Jan 2012
Last updated
15 Feb 2019

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.

    PubMed 30573970

  • 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.

    PubMed 29902295

  • 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.

    PubMed 28577938

  • 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.

    PubMed 26156651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing afatinib and erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 192 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, France, Italy, Germany, United Kingdom and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 (time frame: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01523587, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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