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LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

26 mars 2020 mis à jour par: Boehringer Ingelheim

LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

319

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Essen, Allemagne, 45122
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Esslingen, Allemagne, 73730
        • Klinikum Esslingen GmbH
      • Mainz, Allemagne, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Australie
    • New South Wales
      • Camperdown, New South Wales, Australie, 2050
        • Chris OBrien Lifehouse
      • Kogarah, New South Wales, Australie, 2217
        • St George Hospital
    • Queensland
      • Chermside, Queensland, Australie, 4032
        • The Prince Charles Hospital
      • South Brisbane, Queensland, Australie, 4101
        • Haematology & Oncology Clinics of Australasia (HOCA)
    • Victoria
      • Box Hill, Victoria, Australie, 3128
        • Box Hill Hospital
      • Heidelberg, Victoria, Australie, 3084
        • Austin Health
    • Western Australia
      • Nedlands, Western Australia, Australie, 6009
        • Sir Charles Gairdner Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute (University of Alberta)
    • British Columbia
      • Surrey, British Columbia, Canada, V1V 1Z2
        • British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency - Vancouver
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Centre
  • Chine
      • Beijing, Chine, 100021
        • Cancer Hospital of Chinese Academy of Medical Science
      • Beijing, Chine, 100036
        • Beijing Cancer Hospital
      • Guangzhou, Chine, 510060
        • Sun Yat-sen University Cancer Center
      • Nan Ning, Chine, 530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
      • Shanghai, Chine, 200030
        • Shanghai Chest Hospital
      • Shanghai, Chine, 200032
        • Zhongshan Hospital Fudan University
      • Shenyang, Chine, 110001
        • The First Hospital of Chinese Medical University
  • Corée, République de
      • Cheongju, Corée, République de, 361-771
        • Chungbuk National University Hospital
      • Incheon, Corée, République de, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Corée, République de, 135-710
        • Samsung Medical Center
      • Seoul, Corée, République de, 138-736
        • Asan Medical Center
      • Seoul, Corée, République de, 110-744
        • Seoul National University Hospital
      • Seoul, Corée, République de, 120-752
        • Severance Hospital
  • Espagne
      • Madrid, Espagne, 28041
        • Hospital Universitario 12 de Octubre
      • Malaga, Espagne, 29010
        • Hospital Regional Universitario de Málaga
      • Oviedo, Espagne, 33006
        • Hospital Central de Asturias
      • Santander, Espagne, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Espagne, 41013
        • Hospital Virgen del Rocío
  • France
      • Bayonne, France, 64100
        • CTR Oncologie du Pays Basque, Onco, Bayonne
      • Caen, France, 14076
        • CTR François Baclesse
      • Créteil, France, 94010
        • HOP Intercommunal
      • La Tronche, France, 38700
        • HOP Michallon
      • Limoges Cedex, France, 87042
        • HOP Dupuytren 1
      • Lyon, France, 69373
        • CTR Leon Berard
      • Saint Herblain, France, 44805
        • CTR René Gauducheau
      • St-Pierre - La Réunion, France, 97448
        • HOP Sud-Réunion, Pneumo, Saint Pierre
  • Hong Kong
      • Hongkong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince Of Wales Hospital
  • Irlande
      • Dublin, Irlande, 8
        • St James's Hospital
      • Dublin 9, Irlande, D09 Y5R3
        • Beaumont Hospital
  • Norvège
      • Oslo, Norvège, N-0379
        • Oslo Universitetssykehus HF, Radiumhospitalet
  • Royaume-Uni
      • Aberdeen, Royaume-Uni, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Birmingham, Royaume-Uni, B18 7QH
        • Birmingham City Hospital
      • Cardiff, Royaume-Uni, CF14 2TL
        • Velindre Cancer Centre
      • Edinburgh, Royaume-Uni, EH4 2XU
        • Western General Hospital
      • Guildford, Royaume-Uni, GU2 7XX
        • Royal Surrey County Hospital
  • Singapour
      • Singapore, Singapour, 308433
        • Johns Hopkins Singapore International Medical Center
      • Singapore, Singapour, 169610
        • National Cancer Centre
  • Suède
      • Göteborg, Suède, 413 45
        • Sahlgrenska US, Göteborg
      • Linköping, Suède, 581 85
        • Universitetssjukhuset, Linköping
      • Lund, Suède, 221 85
        • Skånes universitetssjukhus, Lund
      • Stockholm, Suède, 171 76
        • Karolinska Univ. sjukhuset
  • Taïwan
      • Taichung, Taïwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taïwan, 704
        • NCKUH
      • Taipei, Taïwan, 100
        • National Taiwan University Hospital
      • Taipei, Taïwan, 112
        • Taipe Veterans General Hospital
      • Tao-Yuan, Taïwan, 333
        • Chang Gung Memorial Hospital(Linkou)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion criteria:

  1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
  2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
  3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  5. Age >= 18 years.
  6. Adequate organ function as defined by the following criteria:

Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =< 3 x upper limit of normal (ULN), or AST and ALT =<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =<1.5 x ULN Absolute neutrophil count (ANC) >=1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L

Exclusion criteria:

  1. Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
  2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
  3. Major surgery within 4 weeks of study randomisation.
  4. Active brain metastases
  5. Meningeal carcinomatosis.
  6. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
  7. Known pre-existing interstitial lung disease.
  8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
  9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
  10. Women of child-bearing potential (WOCBP) 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.
  11. Pregnancy or breast-feeding.
  12. Active hepatitis and/or known HIV carrier
  13. Any prohibited concomitant medications for therapy with afatinib or gefitinib

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: afatinib
afatinib once daily.
Médicament: Afatinib
afatinib once daily
Autres noms:
  • Giotrif® / Gilotrif®
Comparateur actif: gefitinib
gefitinib once daily
Médicament: gefitinib
Gefitinib once daily

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free Survival
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
Progression-free survival (PFS) defined as the time from date of randomisation to date of disease progression, or date of death if a patient died earlier. Participants with no event (Disease progression (PD) or death) were censored. PD was primarily evaluated for the primary analysis by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started, together with an absolute increase in the SoD of target lesions of at least 5 millimetre (mm) or the appearance of one or more new lesions. For the final analysis (analysis cut-off date 12 April 2019) status and date of PD were determined by investigator assessment.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Délai: From first drug administration until last drug administration, up to 1482 days
Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.
From first drug administration until last drug administration, up to 1482 days
Overall Survival
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
Overall survival (OS) which was defined as the time from the date of randomisation to the date of death. Participants for whom there is no evidence of death at the time of the analysis will be censored at the date that they were last known to be alive.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
Objective response rate (ORR) which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
Time to Objective Response
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
Number of participants with objective response (best overall response of complete response or partial response) to study treatment over time, cumulative number of participants is displayed. Time to objective response was defined as the time from randomisation to the first recorded objective response. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
Duration of Objective Response
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
Duration of objective response defined as the time of first objective response (best overall response of complete response or partial response) to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
Disease Control
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
Percentage of participants with disease control which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Responses of SD were only considered if they occur ≥42 days from date of randomisation. For the final analysis (analysis cut-off date 12 April 2019) disease control was determined by investigator assessment.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
Duration of Disease Control
Délai: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
Duration of disease control defined as the time from randomisation to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) the status and date of disease progression were determined by investigator assessment.
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Délai: From first drug administration until last drug administration, up to 1482 days
Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.
From first drug administration until last drug administration, up to 1482 days
Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)
Délai: Every 8 weeks, up to 56 weeks

Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS).

EQ-5D utility scores range from 0 (worst health) to 1 (full health).

EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

Results display the mean score up to 56 weeks.
Every 8 weeks, up to 56 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 décembre 2011

Achèvement primaire (Réel)

8 avril 2016

Achèvement de l'étude (Réel)

12 avril 2019

Dates d'inscription aux études

Première soumission

4 novembre 2011

Première soumission répondant aux critères de contrôle qualité

4 novembre 2011

Première publication (Estimation)

8 novembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mars 2020

Dernière vérification

1 mars 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1200.123
  • 2011-001814-33 (Numéro EudraCT)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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