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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)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01853826
Collaborator
(none)
481
Enrollment
118
Locations
1
Arm
116.4
Anticipated Duration (Months)
4.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
481 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Jul 17, 2013
Actual Primary Completion Date :
Apr 30, 2018
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: afatinib

Patients will receive afatinib once daily

Drug: afatinib
Patients will receive afatinib once daily

Outcome Measures

Primary Outcome Measures

  1. Adverse Events according to Common Terminology Criteria (CTCAE Version 3) [up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Prince of Wales Hospital Randwick New South Wales Australia 2031
2 Sunshine Hospital AT Albans Victoria Australia 3021
3 St John of God Murdoch Murdoch Western Australia Australia 6150
4 LKH-Univ. Hospital Graz Graz Austria 8036
5 Ordensklinikum Linz GmbH - Barmherzige Schwestern Linz Austria 4010
6 Klinikum Wels - Grieskirchen GmbH Wels Austria 4600
7 Klinik Penzing SMZ Baumgartner Hoehe Wien Austria 1140
8 University Hospital Brno Brno Czechia 625 00
9 Hospital Hradec Kralove Hradec Kralove Czechia 500 05
10 University Hospital Ostrava Ostrava Czechia 708 52
11 University Hospital Plzen, Plzen-Bory Plzen Czechia 305 00
12 Chest Hospital of Athens "Sotiria" Athens Greece 11527
13 Metropolitan Hospital, Oncology Clinic N. Faliro Greece 18547
14 General Oncology Hospital "Agioi Anargyri" Nea Kifisia Greece 14564
15 General Hospital of Thessaloniki "G. Papanikolaou" Thessaloniki Greece 57010
16 National Koranyi TBC and Pulm. Internal Med. Clinic Budapest Hungary 1121
17 Institute of Chest Diseases Csongrad County,Dpt. Pulmonology Deszk Hungary 6772
18 Pulmonology Institute of Veszprem County, Farkasgyepu Farkasgyepü Hungary 8582
19 Fejer County Saint George University Teaching Hospital Szekesfehervar Hungary 8000
20 Soroka Univ. Medical Center Beer Sheva Israel 84101
21 Meir Medical Center Kfar Saba Israel 44281
22 Rabin Medical Center Beilinson Petah Tikva Israel 49100
23 The Chaim Sheba Medical Center Tel HaShomer Tel Hashomer Israel 52621
24 Sourasky Medical Center Tel-Aviv Israel 64239
25 Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo Alessandria Italy 15100
26 Az. Ospedaliere Umberto I di Ancona Ancona Italy 60020
27 A. O. Giuseppe Moscati Avellino Italy 83100
28 Centro di riferimento Oncologico Aviano (PN) Italy 33081
29 Istituto Tumori Giovanni Paolo II Bari Italy 70124
30 A. O. Ospedali Riuniti di Bergamo Bergamo Italy 24127
31 Policlinico S. Orsola Malpighi Bologna Italy 40138
32 Ospedale Centrale di Bolzano Bolzano Italy 39100
33 A.O. Spedali Civili di Brescia Brescia Italy 25123
34 Azienda Ospedaliera Careggi Firenze Italy 50139
35 Azienda Ospedaliera San Martino Genova Italy 16132
36 Osp. S. Maria della Scaletta Imola Italy 40026
37 Azienda Ospedaliera Vito Fazzi Lecce Italy 73100
38 Osp. Campo di Marte Lucca Italy 55100
39 Istituto Scientifico Romagnolo Meldola (FC) Italy 47014
40 IRCCS Fondazione Ospedale Maggiore Milano Italy 20122
41 IRCCS San Raffaele Milano Italy 20132
42 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
43 Istituto Europeo di Oncologia Milano Italy 20141
44 ASST Grande Ospedale Metropolitano Niguarda Milano Italy 20162
45 Università di Modena e Reggio Emilia Modena Italy 41100
46 A.O. San Gerardo di Monza Monza (MI) Italy 20052
47 Istituto Nazionale IRCCS Tumori Fondazione Pascale Napoli Italy 80131
48 Osp. dei Colli Monaldi-Cotugno Napoli Italy 80131
49 A.O.U. Maggiore della Carita' Novara Italy 28100
50 Azienda Sanitaria Ospedale S. Luigi Gonzaga Orbassano (TO) Italy 10043
51 Istituto Oncologico Veneto IRCCS Padova Italy 35128
52 A.O. Univ. Policlinico "Paolo Giaccone" Palermo Italy 90127
53 Casa di Cura La Maddalena Palermo Italy 90146
54 Azienda Ospedaliera di Parma Parma Italy 43100
55 Ospedale S.Maria della Misericordia, AO di Perugia Perugia Italy 06132
56 Azienda Ospedaliera Universitaria Pisana Pisa Italy 56126
57 Ospedale S. Maria delle Croci Ravenna Italy 48121
58 Irccs Crob Rionero In Vulture (PZ) Italy 85028
59 Università Campus Bio-Medico - ROMA Roma Italy 00128
60 Istittuo Nazionale Tumori Regina Elena - IRCCS Roma Italy 00144
61 A.O. San Camillo Forlanini Roma Italy 00152
62 Poli Univ A. Gemelli Roma Italy 00168
63 Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza Roma Italy 00189
64 Azienda Ospedaliera "Santo Maria" Terni Italy 05100
65 AO Città della Salute e Scienza Torino Italy 10129
66 Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO Treviso Italy 31100
67 A. O. S. Maria della Misericordia Udine Italy 33100
68 Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona Verona Italy 37126
69 Oncology Center na F. Lukaszczyka Bydgoszcz Poland 85-796
70 University Clinical Center, Gdansk Gdansk Poland 80-952
71 Provincial Specialist M. Kopernik Hospital Lodz Poland 93-513
72 MS Clinsearch, Private Practice Lublin Poland 20-090
73 MED POLONIA SP Z O O, Clinical Trials Department,Poznan Poznan Poland 60-693
74 Onco.Cent. - Instit. of Maria Sklodowskiej-Curie Warszawa Poland 02-781
75 CHUC - Centro Hospitalar e Universitário de Coimbra, EPE Coimbra Portugal 3041-801
76 IPO Lisboa Francisco Gentil, EPE Lisboa Portugal 1099-023
77 Centro Hospitalar Lisboa Norte Hospital Pulido Valente Lisboa Portugal 1769-001
78 IPO Porto Francisco Gentil, EPE Porto Portugal 4200-072
79 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Portugal 4434-502
80 St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan" Kazan Russian Federation 420029
81 Moscow City Oncology Dispensary, Moscow Moscow Russian Federation 111033
82 FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF Moscow Russian Federation 115478
83 Clinical Oncology Center Omsk Russian Federation 640 013
84 St. Petersburg GUZ City Clinical Oncology Dispensary St. Petersburg Russian Federation 197022
85 FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF St. Petersburg Russian Federation 197758
86 Hospital A Coruña A Coruña Spain 15006
87 Hospital General Universitario de Alicante Alicante Spain 03010
88 Hospital Germans Trias i Pujol Badalona Spain 08916
89 Hospital Universitario de Cruces Barakaldo (Bilbao) Spain 48903
90 Hospital del Mar Barcelona Spain 08003
91 Hospital Vall d'Hebron Barcelona Spain 08035
92 Hospital Clínic de Barcelona Barcelona Spain 08036
93 Hospital Santa Creu i Sant Pau Barcelona Spain 08041
94 Hospital Universitario Reina Sofía Cordoba Spain 14004
95 Hospital Universitario Virgen de las Nieves Granada Spain 18014
96 Hospital Duran i Reynals L'Hospitalet de Llobregat Spain 08908
97 Hospital de Canarias La Laguna - Tenerife Spain 38320
98 Hospital La Princesa Madrid Spain 28006
99 Hospital General Universitario Gregorio Marañón Madrid Spain 28007
100 Hospital Ramón y Cajal Madrid Spain 28034
101 Fundación Jiménez Díaz Madrid Spain 28040
102 Hospital Clínico San Carlos Madrid Spain 28040
103 Hospital Universitario 12 de Octubre Madrid Spain 28041
104 Hospital La Paz Madrid Spain 28046
105 Hospital Puerta de Hierro Majadahonda (Madrid) Spain 28222
106 Hospital Regional Universitario de Málaga Malaga Spain 29010
107 Hospital Virgen de la Victoria Malaga Spain 29010
108 Hospital Central de Asturias Oviedo Spain 33011
109 Hospital Son Espases Palma de Mallorca Spain 07120
110 Hospital de Son Llàtzer Palma de Mallorca Spain 07198
111 Complejo Hospitalario de Navarra Pamplona Spain 31008
112 Hospital Clínico de Santiago Santiago de Compostela Spain 15706
113 Hospital Virgen del Rocío Sevilla Spain 41013
114 Hospital Politècnic La Fe Valencia Spain 46009
115 Hospital Clínico de Valencia Valencia Spain 46010
116 Hospital General Universitario de Valencia Valencia Spain 46014
117 Hospital Clínico Universitario Lozano Blesa Zaragoza Spain 50009
118 Hospital Miguel Servet Zaragoza Spain 50009

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01853826
Other Study ID Numbers:
  • 1200.55
  • 2009-017661-34
First Posted:
May 15, 2013
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Afatinib

Study Results

No Results Posted as of Aug 24, 2022