An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

April 10, 2025 updated by: Boehringer Ingelheim
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

481

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • The Prince of Wales Hospital
    • Victoria
      • AT Albans, Victoria, Australia, 3021
        • Sunshine Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • St John of God Murdoch
  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz State Hospital - University Hospital Graz
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH - Barmherzige Schwestern
      • Wels, Austria, 4600
        • Klinikum Wels - Grieskirchen GmbH
      • Wien, Austria, 1140
        • Klinik Penzing SMZ Baumgartner Hoehe
  • Czechia
      • Brno, Czechia, 625 00
        • University Hospital Brno
      • Hradec Kralove, Czechia, 500 05
        • Hospital Hradec Kralove
      • Ostrava, Czechia, 708 52
        • University Hospital Ostrava
      • Plzen, Czechia, 305 00
        • University Hospital Plzen, Plzen-Bory
  • Greece
      • Athens, Greece, 11527
        • Chest Hospital of Athens "Sotiria"
      • N. Faliro, Greece, 18547
        • Metropolitan Hospital, Oncology Clinic
      • Nea Kifisia, Greece, 14564
        • General Oncology Hospital "Agioi Anargyri"
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessaloniki "G. Papanikolaou"
  • Hungary
      • Budapest, Hungary, 1121
        • Koranyi National Institute For Pulmonolgy
      • Deszk, Hungary, 6772
        • Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
      • Farkasgyepü, Hungary, 8582
        • Pulmonology Institute of Veszprem County, Farkasgyepu
      • Szekesfehervar, Hungary, 8000
        • Fejer County Saint George University Teaching Hospital
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka Univ. Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center Beilinson
      • Tel Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center Tel HaShomer
      • Tel-Aviv, Israel, 64239
        • Sourasky Medical Center
  • Italy
      • Alessandria, Italy, 15100
        • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy, 60020
        • Az. Ospedaliere Umberto I di Ancona
      • Avellino, Italy, 83100
        • A. O. Giuseppe Moscati
      • Aviano (PN), Italy, 33081
        • Centro di riferimento Oncologico
      • Bari, Italy, 70124
        • Istituto Tumori Giovanni Paolo II
      • Bergamo, Italy, 24127
        • A. O. Ospedali Riuniti di Bergamo
      • Bologna, Italy, 40138
        • Policlinico S. Orsola Malpighi
      • Bolzano, Italy, 39100
        • Ospedale Centrale di Bolzano
      • Brescia, Italy, 25123
        • A.O. Spedali Civili di Brescia
      • Firenze, Italy, 50139
        • Azienda Ospedaliera Careggi
      • Genova, Italy, 16132
        • Azienda Ospedaliera San Martino
      • Imola, Italy, 40026
        • Osp. S. Maria della Scaletta
      • Lecce, Italy, 73100
        • Azienda Ospedaliera Vito Fazzi
      • Lucca, Italy, 55100
        • Osp. Campo di Marte
      • Meldola (FC), Italy, 47014
        • Istituto Scientifico Romagnolo
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milano, Italy, 20122
        • IRCCS Fondazione Ospedale Maggiore
      • Milano, Italy, 20132
        • IRCCS San Raffaele
      • Modena, Italy, 41100
        • Università di Modena e Reggio Emilia
      • Monza (MI), Italy, 20052
        • A.O. San Gerardo di Monza
      • Napoli, Italy, 80131
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
      • Napoli, Italy, 80131
        • Osp. dei Colli Monaldi-Cotugno
      • Novara, Italy, 28100
        • A.O.U. Maggiore della Carita'
      • Orbassano (TO), Italy, 10043
        • Azienda Sanitaria Ospedale S. Luigi Gonzaga
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IRCCS
      • Palermo, Italy, 90127
        • A.O. Univ. Policlinico "Paolo Giaccone"
      • Palermo, Italy, 90146
        • Casa di Cura La Maddalena
      • Parma, Italy, 43100
        • Azienda Ospedaliera Di Parma
      • Perugia, Italy, 06132
        • Ospedale S.Maria della Misericordia, AO di Perugia
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana
      • Ravenna, Italy, 48121
        • Ospedale S. Maria Delle Croci
      • Rionero In Vulture (PZ), Italy, 85028
        • Irccs Crob
      • Roma, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
      • Roma, Italy, 00168
        • Poli Univ A. Gemelli
      • Roma, Italy, 00152
        • A.O. San Camillo Forlanini
      • Roma, Italy, 00128
        • Università Campus Bio-Medico - ROMA
      • Roma, Italy, 00144
        • Istittuo Nazionale Tumori Regina Elena - IRCCS
      • Terni, Italy, 05100
        • Azienda Ospedaliera "Santo Maria"
      • Torino, Italy, 10129
        • AO Città della Salute e Scienza
      • Treviso, Italy, 31100
        • Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
      • Udine, Italy, 33100
        • A. O. S. Maria della Misericordia
      • Verona, Italy, 37126
        • Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Oncology Center na F. Lukaszczyka
      • Gdansk, Poland, 80-952
        • University Clinical Center, Gdansk
      • Lodz, Poland, 93-513
        • Provincial Specialist M. Kopernik Hospital
      • Lublin, Poland, 20-090
        • MS Clinsearch, Private Practice
      • Poznan, Poland, 60-693
        • MED POLONIA SP Z O O, Clinical Trials Department,Poznan
      • Warszawa, Poland, 02-781
        • Oncology Center-Maria Sklodowska-Curie Institute
  • Portugal
      • Coimbra, Portugal, 3041-801
        • ULS de Coimbra, E.P.E.
      • Lisboa, Portugal, 1099-023
        • IPO Lisboa Francisco Gentil, EPE
      • Lisboa, Portugal, 1769-001
        • Centro Hospitalar Lisboa Norte Hospital Pulido Valente
      • Porto, Portugal, 4200-072
        • IPO Porto Francisco Gentil, EPE
      • Vila Nova de Gaia, Portugal, 4434-502
        • ULS de Gaia/Espinho, EPE
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
      • Moscow, Russian Federation, 111033
        • Moscow City Oncology Dispensary, Moscow
      • Moscow, Russian Federation, 115478
        • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
      • Omsk, Russian Federation, 640 013
        • Clinical Oncology Center
      • St. Petersburg, Russian Federation, 197022
        • St. Petersburg GUZ City Clinical Oncology Dispensary
      • St. Petersburg, Russian Federation, 197758
        • FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
  • Spain
      • A Coruña, Spain, 15006
        • Hospital A Coruña
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barakaldo (Bilbao), Spain, 48903
        • Hospital Universitario de Cruces
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • L'Hospitalet de Llobregat, Spain, 08908
        • Hospital Duran i Reynals
      • La Laguna - Tenerife, Spain, 38320
        • Hospital de Canarias
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Majadahonda (Madrid), Spain, 28222
        • Hospital Puerta de Hierro
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Oviedo, Spain, 33011
        • Hospital Central de Asturias
      • Palma de Mallorca, Spain, 07120
        • Hospital Son Espases
      • Palma de Mallorca, Spain, 07198
        • Hospital de Son Llàtzer
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico de Santiago
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46009
        • Hospital Politècnic La Fe
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Patients with:

  • locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
  • Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.

  • Adequate organ function, defined as all of the following:

    1. Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
    2. Platelet count >75,000/mm3
    3. Serum creatinine < 1.5 times of the upper limit of normal
    4. Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
    5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN).
  • Eastern Cooperative Oncology Group (ECOG) score between 0 - 2
  • written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

Exclusion criteria:

Patients who or with:

  • prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
  • anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)

  • radiotherapy within 14 days prior to drug administration, except as follows:

    1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
    2. Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  • 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.
  • known pre-existing interstitial lung disease
  • meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afatinib treated-patients
Patients diagnosed with EGFR mutation positive non-small cell lung cancer (NSCLC) locally advanced or metastatic who have never been treated with EGFR tyrosine kinase inhibitors (TKI) received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.
Drug: Afatinib
Patients received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.
Other Names:
  • Giotrif®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time Frame: From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.
Number of patients with any treatment emergent adverse event (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2013

Primary Completion (Actual)

March 6, 2024

Study Completion (Actual)

March 6, 2024

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimated)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.55
  • 2009-017661-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

IPD Sharing Time Frame

After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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