AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT00949650

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

A Phase 3 study testing Pemetrexed, BIBW 2992 and Cisplatin in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, run by Boehringer Ingelheim at 133 sites in 25 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 adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pemetrexed, BIBW 2992 and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
133 sitesin 25 countries
Study dates
14 Aug 2009to 16 Mar 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

  • Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
  • Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
  • Measurable disease according to RECIST 1.1.
  • Eastern Cooperative Oncology Group score of 0 or 1.
  • Age >/= 18 years.
  • Life expectancy of at least three months.
  • Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.

Who cannot join

  • Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
  • Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
  • Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
  • Active brain metastases
  • Any other current malignancy or malignancy diagnosed within the past five years
  • Known pre-existing interstitial lung disease.
Show all 12Show fewer
  • Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  • History or presence of clinically relevant cardiovascular abnormalities.
  • Any other concomitant serious illness or organ system dysfunction.
  • Adequate absolute neutrophil count and platelet count
  • Adequate liver and kidney function
  • Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

Trial locations and contacts

133 sites in 25 countries.

133 sites in 25 countries

Japan16 sites

  • National Hospital Organization Nagoya Medical Center

    Aichi, Nagoya, 460-0001

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • National Hospital Organization Shikoku Cancer Center

    Ehime, Matsuyama, 791-0280

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Institute of Biomedical Research and Innovation Hospital

    Hyogo, Kobe, 650-0047

  • Kanazawa University Hospital

    Ishikawa, Kanazawa, 920-8641

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Kurashiki Central Hospital

    Okayama, Kurashiki, 710-8602

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Kindai University Hospital

    Osaka, Osaka-Sayama, 589-8511

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, Osaka, 591-8555

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777

Other trials in Japan

Australia9 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Lifehouse

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • St. Vincents Hospital (MEL)

    Fitzroy, Victoria, 3065

  • Mount Medical Centre

    Perth, Western Australia, 6000

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • The Burnside War Memorial Hospital

    Toorak Gardens, South Australia, 5065

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

France9 sites

  • HOP d'Angers

    Angers, 49933

  • HOP Côte de Nacre

    Caen, 14033

  • HOP Nord Michallon

    La Tronche, 38700

  • HOP Croix Rousse, Pneumo, Lyon

    Lyon, 69317

  • INS Curie

    Paris, 75248

  • HOP Sud-Réunion, Pneumo, Saint Pierre

    Saint Pierre - La Réunion, 97448

  • CTR René Gauducheau

    Saint-Herblain, 44805

  • HOP - HIA Sainte Anne

    Toulon, 83041

  • HOP, Pneumo, Villefranche sur Saône

    Villefranche-sur-Saône, 69655

Other trials in France

Argentina8 sites

  • Instituto de Medicina Nuclear de Bahía Blanca

    Bahía Blanca, B8000FJI

  • Hospital Alemán

    Capital Federal, C1118AAT

  • Imcaba S.R.L.

    Capital Federal, C1185AAT

  • IMAI Research

    Capital Federal, C1425AWC

  • Instituto Alexander Fleming

    Capital Federal, C1426ANZ

  • Hospital Militar Central

    Capital Federal, C1426BOR

  • PALIAR

    Capital Federal, C1430ERF

  • Centro Oncológico de Rosario

    Rosario, S2000KZE

Other trials in Argentina

Germany8 sites

  • Universitätsklinikum Benjamin Franklin, Berlin

    Berlin, 12200

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45122

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Lungenklinik Hemer

    Hemer, 58675

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55101

  • Universitätsklinikum Münster

    Münster, 48149

  • Pius-Hospital, Oldenburg

    Oldenburg, 26121

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Germany

Taiwan8 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • NCKUH

    Tainan, 704

  • Taipe Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 114

  • Chang Gung Memorial Hospital(TaoYuan)

    Taoyuan, 33305

Other trials in Taiwan

United States7 sites

  • Lehigh Valley Hospital / Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • South Texas Institute of Cancer, Northwest Cancer Center

    Corpus Christi, Texas, 78410

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Crescent City Research Consortiom

    Marrero, Louisiana, 70072

  • Innovative Medical Research of South Florida

    Miami, Florida, 33179

  • Clinical Trials and Research Associates Inc

    Montebello, California, 90640

  • Interlakes Foundation, Incorporated

    Rochester, New York, 14623

Other trials in United States

United Kingdom7 sites

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • The Royal Marsden Hospital

    London, SW3 6JJ

  • Maidstone Hospital, Kent Oncology Centre

    Maidstone, ME16 9QQ

  • Scunthorpe General Hospital, Oncology

    Scunthorpe, DN15 7BH

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

Russia6 sites

  • Republic Clinical Oncology Dispensary, Dept. Chemotherapy

    Kazan', 420029

  • FSBSI "N.N Blokhin Medical Research Center of Oncology"

    Moscow, 115478

  • Medical Radiology Science Centre

    Obninsk, 249020

  • First Pavlov State Medical University Saint Petersburg

    Saint Petersburg, 197022

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

  • FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

    Saint Petersburg, 197758

Other trials in Russia

Belgium5 sites

  • Brussels - UNIV St-Pierre

    Brussels, 1000

  • UNIV UZ Gent

    Ghent, 9000

  • Brussels - UNIV UZ Brussel

    Jette, 1090

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Brazil5 sites

  • Centro de Pesquisa do Hospital Lifecenter

    Belo Horizonte

  • Centro de Pesquisas Clínicas em Oncología

    Cachoeiro de Itapemirim, 29308-014

  • Insituto de Oncologia do Paraná

    Curitiba, 80530-010

  • Hospital São Lucas da Pontifícia Universidade Católica

    Porto Alegre, 90610-000

  • UNIFESP Departamento de Medicina de Pneumologia

    São Paulo, 04023-900

Other trials in Brazil

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute (University of Alberta)

    Edmonton, Alberta, T6G 1Z2

  • Charles LeMoyne Hospital

    Greenfield Park, Migration Data, J4V 2H1

  • Hematologiste et oncologue medical CHUM - Hopital Notre-Dame

    Montreal, Migration Data, H2L 4M1

  • McGill University, Department of Oncology

    Montreal, Migration Data, H2W 1S6

Other trials in Canada

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, 361-771

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-763

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Asan Medical Center

    Seoul, 138-736

  • Ulsan University Hospital

    Ulsan, 682-714

Other trials in South Korea

Italy4 sites

  • Ospedale San Donato di Arezzo

    Arezzo, 52100

  • Az. USL 4 di Prato

    Prato, 59100

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

  • Osp. Silvestrin

    Sant'Andrea Delle Fratte (PG), 06132

Other trials in Italy

Thailand4 sites

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khonkaen, 40002

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Ukraine4 sites

  • City Clinical Hospital #4, Dnipropetrovsk State Medical Academy

    Dnipropetrovsk, 49102

  • Donetsk Regional Antitumor Centre

    Donetsk, 83000

  • Kharkiv Regional Clinical Oncology Center

    Kharkiv, 16070

  • Lviv State Oncological Regional Treatment & Diagnostic CTR

    Lviv, 79031

Other trials in Ukraine

Austria3 sites

  • KH d. Elisabethinen Linz

    Linz, 4010

  • SMZ Baumgartner Hoehe Otto Wagner Spital

    Vienna, 1140

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Chile3 sites

  • Hospital Dirección de Previsión de Carabineros

    Los Condes, 760-0746

  • Instituto Oncológico Limitada Viña del Mar

    Reñaca, 2540364

  • Instituto Clínico Oncológico del Sur - ICOS

    Temuco

Other trials in Chile

Hungary3 sites

  • Szent György Hospital, Szekesfehervar

    Székesfehérvár, 8000

  • Markusovszky County Hospital, Szombathely

    Szombathely, 9700

  • Zala County Hospital, Zalaegerszeg

    Zalaegerszeg, 8900

Other trials in Hungary

Malaysia3 sites

  • Hospital Pulau Pinang

    Palau Pinang, 10990

  • Pusat Perubatan University Kebangsaan Malaysia

    Wilayah Persekutuan, 5600

  • University Malaya Medical Centre

    Wilayah Persekutuan, 59100

Other trials in Malaysia

Peru3 sites

  • Hospital Nacional Guillermo Almenara Irigoyen

    La Victoria

  • Clínica Anglo Americana

    San Isidro, 27

  • Instituto Nacional de Enfermedades Neoplásicas

    Surquillo, 34

Other trials in Peru

Philippines3 sites

  • Perpetual Succour Hospital (Cebu)

    Cebu City, 6000

  • Makati Medical Center

    Makati City, 1229

  • St. Luke Medical Centre

    Quezon, 1102

Other trials in Philippines

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Romania2 sites

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, 400015

  • ONCOLAB SRL, Craiova

    Craiova, 200535

Other trials in Romania

Ireland1 site

  • St James's Hospital

    Dublin

Other trials in Ireland

About this study

Official title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

Being tested
Pemetrexed, BIBW 2992, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

What participants receive

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

  • PemetrexedDrug

    Pemetrexed IV given once every 3 weeks for up to 6 cycles

  • BIBW 2992Drug

    BIBW 2992 once daily until progression

  • CisplatinDrug

    Cisplatin IV given once every 3 weeks for up to 6 cycles

Study groups in NCT00949650
Study groupRoleWhat they receive
BIBW 2992ExperimentalBIBW 2992 tablet once daily until progression
Receives: Drug: BIBW 2992
Cisplatin/PemetrexedActive comparatorCisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
Receives: Drug: Pemetrexed; Drug: Cisplatin

What is being measured

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

  1. Progression-Free Survival (PFS) Time

    PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.

    Measured: Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression

Secondary outcomes (12)

  1. Percentage of Patients With Objective Response (OR)

    OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.

    Measured: Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression

  2. Percentage of Participants With Disease Control (DC)

    DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.

    Measured: Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression

  3. Overall Survival (OS) Time

    OS was defined as time from randomisation to death.

    Measured: From randomisation to cut-off date (17MAR2017).

  4. Tumour Shrinkage

    Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.

    Measured: Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression

  5. Change From Baseline in Body Weight

    Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.

    Measured: Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.

  6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.

    1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.
    2. Ambulatory (>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.
    3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.
    4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair.
    5. Dead.

    Measured: Throughout the trial until progression (every 3 weeks), up to 28 months.

  7. Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing

    HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.

    Measured: Throughout the trial until progression (every 3 weeks).

  8. HRQOL: Time to Deterioration in Dyspnoea

    HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.

    Measured: Throughout the trial until progression (every 3 weeks).

  9. HRQOL: Time to Deterioration in Pain

    HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.

    Measured: Throughout the trial until progression (every 3 weeks).

  10. Trough Plasma Concentrations of Afatinib at Day 22

    Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.

    Measured: Day 22.

  11. Trough Plasma Concentrations of Afatinib at Day 29

    Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.

    Measured: Day 29.

  12. Trough Plasma Concentrations of Afatinib at Day 43

    Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.

    Measured: Day 43.

Timeline

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

  1. First posted30 Jul 2009 (estimated)
  2. Study start14 Aug 2009
  3. Primary completion9 Feb 2012
  4. Study completion16 Mar 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
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949650
Sponsor's protocol ID
1200.32
Other IDs
2008-005615-18, 2008
Status last verified
Mar 2018
First submitted
29 Jul 2009
Last updated
6 Apr 2018

Publications

  • Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations. J Clin Oncol. 2023 Jun 1;41(16):2869-2876. doi: 10.1200/JCO.22.02547.

    PubMed 37235976

  • Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

    PubMed 29653820

  • Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Marten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. doi: 10.1093/annonc/mdw322. Epub 2016 Sep 6.

    PubMed 27601237

  • Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.

    PubMed 26823294

  • Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.

    PubMed 26094656

  • Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.

    PubMed 26051236

  • Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.

    PubMed 25589191

  • Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.

    PubMed 23816967

  • Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.

    PubMed 23816960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed, BIBW 2992 and Cisplatin in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, run by Boehringer Ingelheim at 133 sites in 25 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 7 inclusion and 12 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Japan, Australia, France, Argentina, Germany and 20 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 19 Nov 2013). 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 (PFS) Time (time frame: Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression). 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 NCT00949650, which also lists 9 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 6 Apr 2018.

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