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AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT01853826

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)

A Phase 3 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 118 sites in 11 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

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 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
481 participants
Where
118 sitesin 11 countries
Study dates
17 Jul 2013to 6 Mar 2024
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

  • 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:
  • 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).
  • Platelet count >75,000/mm3
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  • Serum creatinine < 1.5 times of the upper limit of normal
  • 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).
  • 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.

Who cannot join

  • 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:
  • Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
  • Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Show all 9Show fewer
  • 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)

Trial locations and contacts

118 sites in 11 countries.

118 sites in 11 countries

Italy44 sites

  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15100

  • Az. Ospedaliere Umberto I di Ancona

    Ancona, 60020

  • A. O. Giuseppe Moscati

    Avellino, 83100

  • Centro di riferimento Oncologico

    Aviano (PN), 33081

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • A. O. Ospedali Riuniti di Bergamo

    Bergamo, 24127

  • Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Ospedale Centrale di Bolzano

    Bolzano, 39100

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera Careggi

    Florence, 50139

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • Osp. S. Maria della Scaletta

    Imola, 40026

  • Azienda Ospedaliera Vito Fazzi

    Lecce, 73100

  • Osp. Campo di Marte

    Lucca, 55100

  • Istituto Scientifico Romagnolo

    Meldola (FC), 47014

  • IRCCS Fondazione Ospedale Maggiore

    Milan, 20122

  • IRCCS San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Università di Modena e Reggio Emilia

    Modena, 41100

  • A.O. San Gerardo di Monza

    Monza (MI), 20052

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131

  • Osp. dei Colli Monaldi-Cotugno

    Naples, 80131

  • A.O.U. Maggiore della Carita'

    Novara, 28100

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano (TO), 10043

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • A.O. Univ. Policlinico "Paolo Giaccone"

    Palermo, 90127

  • Casa di Cura La Maddalena

    Palermo, 90146

  • Azienda Ospedaliera di Parma

    Parma, 43100

  • Ospedale S.Maria della Misericordia, AO di Perugia

    Perugia, 06132

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

  • Ospedale S. Maria delle Croci

    Ravenna, 48121

  • Irccs Crob

    Rionero in Vulture (PZ), 85028

  • Università Campus Bio-Medico - ROMA

    Roma, 00128

  • Istittuo Nazionale Tumori Regina Elena - IRCCS

    Roma, 00144

  • A.O. San Camillo Forlanini

    Roma, 00152

  • Poli Univ A. Gemelli

    Roma, 00168

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

    Roma, 00189

  • Azienda Ospedaliera "Santo Maria"

    Terni, 05100

  • AO Città della Salute e Scienza

    Torino, 10129

  • Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

    Treviso, 31100

  • A. O. S. Maria della Misericordia

    Udine, 33100

  • Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona

    Verona, 37126

Other trials in Italy

Spain33 sites

  • Hospital A Coruña

    A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario de Cruces

    Barakaldo (Bilbao), 48903

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

  • Hospital de Canarias

    La Laguna - Tenerife, 38320

  • Hospital La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital La Paz

    Madrid, 28046

  • Hospital Puerta de Hierro

    Majadahonda (Madrid), 28222

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Central de Asturias

    Oviedo, 33011

  • Hospital Son Espases

    Palma de Mallorca, 07120

  • Hospital de Son Llàtzer

    Palma de Mallorca, 07198

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Politècnic La Fe

    Valencia, 46009

  • Hospital Clínico de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Poland6 sites

  • Oncology Center na F. Lukaszczyka

    Bydgoszcz, 85-796

  • University Clinical Center, Gdansk

    Gdansk, 80-952

  • Provincial Specialist M. Kopernik Hospital

    Lodz, 93-513

  • MS Clinsearch, Private Practice

    Lublin, 20-090

  • MED POLONIA SP Z O O, Clinical Trials Department,Poznan

    Poznan, 60-693

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781

Other trials in Poland

Russia6 sites

  • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

    Kazan', 420029

  • Moscow City Oncology Dispensary, Moscow

    Moscow, 111033

  • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

    Moscow, 115478

  • Clinical Oncology Center

    Omsk, 640 013

  • St. Petersburg GUZ City Clinical Oncology 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

Israel5 sites

  • Soroka Univ. Medical Center

    Beersheba, 84101

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center Beilinson

    Petah Tikva, 4941492

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center Tel HaShomer

    Tel HaShomer, 52621

Other trials in Israel

Portugal5 sites

  • ULS de Coimbra, E.P.E.

    Coimbra, 3041-801

  • IPO Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente

    Lisbon, 1769-001

  • IPO Porto Francisco Gentil, EPE

    Porto, 4200-072

  • ULS de Gaia/Espinho, EPE

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Austria4 sites

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, 4010

  • Klinik Penzing SMZ Baumgartner Hoehe

    Vienna, 1140

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Czechia4 sites

  • University Hospital Brno

    Brno, 625 00

  • Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Ostrava

    Ostrava, 708 52

  • University Hospital Plzen, Plzen-Bory

    Pilsen, 305 00

Other trials in Czechia

Greece4 sites

  • Chest Hospital of Athens "Sotiria"

    Athens, 11527

  • Metropolitan Hospital, Oncology Clinic

    N. Faliro, 18547

  • General Oncology Hospital "Agioi Anargyri"

    Nea Kifissia, 14564

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

Hungary4 sites

  • Koranyi National Institute For Pulmonolgy

    Budapest, 1121

  • Institute of Chest Diseases Csongrad County,Dpt. Pulmonology

    Deszk, 6772

  • Pulmonology Institute of Veszprem County, Farkasgyepu

    Farkasgyepü, 8582

  • Fejer County Saint George University Teaching Hospital

    Székesfehérvár, 8000

Other trials in Hungary

Australia3 sites

  • Sunshine Hospital

    AT Albans, Victoria, 3021

  • St John of God Murdoch

    Murdoch, Western Australia, 6150

  • The Prince of Wales Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

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

Being tested
Afatinib
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

    Also called Giotrif®

    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.

Study groups in NCT01853826
Study groupRoleWhat they receive
Afatinib treated-patientsExperimentalPatients 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.
Receives: Drug: Afatinib

What is being measured

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

  1. Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

    Number of patients with any treatment emergent adverse event (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Measured: From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.

Timeline

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

  1. First posted15 May 2013 (estimated)
  2. Study start17 Jul 2013
  3. Primary completion6 Mar 2024
  4. Study completion6 Mar 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01853826
Sponsor's protocol ID
1200.55
Other IDs
2009-017661-34, 2009
Status last verified
Apr 2025
First submitted
13 May 2013
Last updated
11 Apr 2025
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 118 sites in 11 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 11 inclusion and 9 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in Italy, Spain, Poland, Russia, Israel and 6 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 11 Apr 2025). 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?

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.). 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 NCT01853826.

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 11 Apr 2025.

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