Carcinoma, Non-Small-Cell LungNCT02131259

Long-term Observation PMS for Afatinib

An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 432 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: Afatinib dimaleate
How many people: 1,605 participants
Where: 432 sitesJapan
Study dates: 7 May 2014to 28 Dec 2016
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 1500

Who may be able to join

Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.

Who cannot join

None

Trial locations and contacts

432 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Boehringer Ingelheim Investigational Site 145
Adachi Tokyo
Boehringer Ingelheim Investigational Site 429
Aira Kagoshima
Boehringer Ingelheim Investigational Site 64
Aizuwakamatsu Fukushima
Boehringer Ingelheim Investigational Site 44
Akita Akita
Boehringer Ingelheim Investigational Site 45
Akita Akita
Boehringer Ingelheim Investigational Site 46
Akita Akita
Boehringer Ingelheim Investigational Site 47
Akita Akita
Boehringer Ingelheim Investigational Site 333
Amagasaki Hyogo
Boehringer Ingelheim Investigational Site 266
Anjo Aichi
Boehringer Ingelheim Investigational Site 27
Aomori Aomori
Boehringer Ingelheim Investigational Site 28
Aomori Aomori
Boehringer Ingelheim Investigational Site 127
Asahi Chiba
Boehringer Ingelheim Investigational Site 128
Asahi Chiba
Boehringer Ingelheim Investigational Site 18
Asahikawa Hokkaido
Boehringer Ingelheim Investigational Site 19
Asahikawa Hokkaido
Boehringer Ingelheim Investigational Site 20
Asahikawa Hokkaido
Boehringer Ingelheim Investigational Site 21
Asahikawa Hokkaido
Boehringer Ingelheim Investigational Site 198
Atsugi Kanagawa
Boehringer Ingelheim Investigational Site 294
Ayabe Kyoto
Boehringer Ingelheim Investigational Site 142
Bunkyo Tokyo
Boehringer Ingelheim Investigational Site 143
Bunkyo Tokyo
Boehringer Ingelheim Investigational Site 144
Bunkyo Tokyo
Boehringer Ingelheim Investigational Site 112
Chiba Chiba
Boehringer Ingelheim Investigational Site 113
Chiba Chiba
Boehringer Ingelheim Investigational Site 114
Chiba Chiba
Boehringer Ingelheim Investigational Site 115
Chiba Chiba
Boehringer Ingelheim Investigational Site 116
Chiba Chiba
Boehringer Ingelheim Investigational Site 117
Chiba Chiba
Boehringer Ingelheim Investigational Site 402
Chikugo Fukuoka
Boehringer Ingelheim Investigational Site 16
Chitose Hokkaido
Boehringer Ingelheim Investigational Site 132
Chiyoda Tokyo
Boehringer Ingelheim Investigational Site 133
Chiyoda Tokyo
Boehringer Ingelheim Investigational Site 134
Chiyoda Tokyo
Boehringer Ingelheim Investigational Site 135
Chuo Tokyo
Boehringer Ingelheim Investigational Site 136
Chuo Tokyo
Boehringer Ingelheim Investigational Site 234
Chuo Yamanashi
Boehringer Ingelheim Investigational Site 235
Chuo Yamanashi
Boehringer Ingelheim Investigational Site 48
Daisen Akita
Boehringer Ingelheim Investigational Site 147
Edogawa Tokyo
Boehringer Ingelheim Investigational Site 148
Edogawa Tokyo
Boehringer Ingelheim Investigational Site 173
Fuchu Tokyo
Boehringer Ingelheim Investigational Site 257
Fuji Shizuoka
Boehringer Ingelheim Investigational Site 260
Fujieda Shizuoka
Boehringer Ingelheim Investigational Site 97
Fujioka Gumma
Boehringer Ingelheim Investigational Site 203
Fujisawa Kanagawa
Boehringer Ingelheim Investigational Site 111
Fukaya Saitama
Boehringer Ingelheim Investigational Site 231
Fukui Fukui
Boehringer Ingelheim Investigational Site 232
Fukui Fukui
Boehringer Ingelheim Investigational Site 393
Fukuoka Fukuoka
Boehringer Ingelheim Investigational Site 394
Fukuoka Fukuoka
Boehringer Ingelheim Investigational Site 395
Fukuoka Fukuoka
Boehringer Ingelheim Investigational Site 396
Fukuoka Fukuoka
Boehringer Ingelheim Investigational Site 399
Fukuoka Fukuoka
Boehringer Ingelheim Investigational Site 58
Fukushima Fukushima
Boehringer Ingelheim Investigational Site 59
Fukushima Fukushima
Boehringer Ingelheim Investigational Site 60
Fukushima Fukushima
Boehringer Ingelheim Investigational Site 356
Fukuyama Hiroshima
Boehringer Ingelheim Investigational Site 357
Fukuyama Hiroshima
Boehringer Ingelheim Investigational Site 121
Funabashi Chiba
Boehringer Ingelheim Investigational Site 251
Gifu Gifu
Boehringer Ingelheim Investigational Site 252
Gifu Gifu
Boehringer Ingelheim Investigational Site 432
Ginowan Okinawa
Boehringer Ingelheim Investigational Site 321
Habikino Osaka
Boehringer Ingelheim Investigational Site 29
Hachinohe Aomori
Boehringer Ingelheim Investigational Site 30
Hachinohe Aomori
Boehringer Ingelheim Investigational Site 176
Hachioji Tokyo
Boehringer Ingelheim Investigational Site 209
Hadano Kanagawa
Boehringer Ingelheim Investigational Site 3
Hakodate Hokkaido
Boehringer Ingelheim Investigational Site 349
Hamada Shimane
Boehringer Ingelheim Investigational Site 261
Hamamatsu Shizuoka
Boehringer Ingelheim Investigational Site 367
Hatsukaichi Hiroshima
Boehringer Ingelheim Investigational Site 107
Hidaka Saitama
Boehringer Ingelheim Investigational Site 76
Higashiibaraki Ibaraki
Boehringer Ingelheim Investigational Site 53
Higashiokitama Yamagata
Boehringer Ingelheim Investigational Site 54
Higashiokitama Yamagata
Boehringer Ingelheim Investigational Site 318
Higashiosaka Osaka
Boehringer Ingelheim Investigational Site 339
Himeji Hyogo
Boehringer Ingelheim Investigational Site 316
Hirakata Osaka
Boehringer Ingelheim Investigational Site 317
Hirakata Osaka
Boehringer Ingelheim Investigational Site 208
Hiratsuka Kanagawa
Boehringer Ingelheim Investigational Site 31
Hirosaki Aomori
Boehringer Ingelheim Investigational Site 32
Hirosaki Aomori
Boehringer Ingelheim Investigational Site 359
Hiroshima Hiroshima
Boehringer Ingelheim Investigational Site 360
Hiroshima Hiroshima
Boehringer Ingelheim Investigational Site 361
Hiroshima Hiroshima
Boehringer Ingelheim Investigational Site 362
Hiroshima Hiroshima
Boehringer Ingelheim Investigational Site 363
Hiroshima Hiroshima
Boehringer Ingelheim Investigational Site 364
Hiroshima Hiroshima
Boehringer Ingelheim Investigational Site 79
Hitachi Ibaraki
Boehringer Ingelheim Investigational Site 77
Hitachinaka Ibaraki
Boehringer Ingelheim Investigational Site 78
Hitachinaka Ibaraki
Boehringer Ingelheim Investigational Site 312
Ibaraki Osaka
Boehringer Ingelheim Investigational Site 131
Ichihara Chiba
Boehringer Ingelheim Investigational Site 120
Ichikawa Chiba
Boehringer Ingelheim Investigational Site 246
Iida Nagano
Boehringer Ingelheim Investigational Site 247
Iida Nagano
Boehringer Ingelheim Investigational Site 309
Ikeda Osaka
Boehringer Ingelheim Investigational Site 248
Ina Nagano
Boehringer Ingelheim Investigational Site 118
Inzai Chiba
Boehringer Ingelheim Investigational Site 105
Iruma Saitama
Boehringer Ingelheim Investigational Site 428
Isa Kagoshima
Boehringer Ingelheim Investigational Site 407
Isahaya Nagasaki
Boehringer Ingelheim Investigational Site 281
Ise Mie
Boehringer Ingelheim Investigational Site 95
Isesaki Gumma
Boehringer Ingelheim Investigational Site 168
Itabashi Tokyo
Boehringer Ingelheim Investigational Site 65
Iwaki Fukushima
Boehringer Ingelheim Investigational Site 368
Iwakuni Yamaguchi
Boehringer Ingelheim Investigational Site 17
Iwamizawa Hokkaido
Boehringer Ingelheim Investigational Site 324
Izumi Osaka
Boehringer Ingelheim Investigational Site 348
Izumo Shimane
Boehringer Ingelheim Investigational Site 255
Izunokuni Shizuoka
Boehringer Ingelheim Investigational Site 213
Joetsu Niigata
Boehringer Ingelheim Investigational Site 214
Joetsu Niigata
Boehringer Ingelheim Investigational Site 289
Joyo Kyoto
Boehringer Ingelheim Investigational Site 422
Kagoshima Kagoshima
Boehringer Ingelheim Investigational Site 423
Kagoshima Kagoshima
Boehringer Ingelheim Investigational Site 424
Kagoshima Kagoshima
Boehringer Ingelheim Investigational Site 425
Kagoshima Kagoshima
Boehringer Ingelheim Investigational Site 426
Kagoshima Kagoshima
Boehringer Ingelheim Investigational Site 262
Kakegawa Shizuoka
Boehringer Ingelheim Investigational Site 340
Kakogawa Hyogo
Boehringer Ingelheim Investigational Site 201
Kamakura Kanagawa
Boehringer Ingelheim Investigational Site 202
Kamakura Kanagawa
Boehringer Ingelheim Investigational Site 130
Kamogawa Chiba
Boehringer Ingelheim Investigational Site 223
Kanazawa Ishikawa
Boehringer Ingelheim Investigational Site 224
Kanazawa Ishikawa
Boehringer Ingelheim Investigational Site 225
Kanazawa Ishikawa
Boehringer Ingelheim Investigational Site 226
Kanazawa Ishikawa
Boehringer Ingelheim Investigational Site 227
Kanazawa Ishikawa
Boehringer Ingelheim Investigational Site 74
Kasama Ibaraki
Boehringer Ingelheim Investigational Site 343
Kashihara Nara
Boehringer Ingelheim Investigational Site 123
Kashiwa Chiba
Boehringer Ingelheim Investigational Site 124
Kashiwa Chiba
Boehringer Ingelheim Investigational Site 125
Kashiwa Chiba
Boehringer Ingelheim Investigational Site 104
Kasukabe Saitama
Boehringer Ingelheim Investigational Site 106
Kawagoe Saitama
Boehringer Ingelheim Investigational Site 100
Kawaguchi Saitama
Boehringer Ingelheim Investigational Site 99
Kawaguchi Saitama
Boehringer Ingelheim Investigational Site 182
Kawasaki Kanagawa
Boehringer Ingelheim Investigational Site 183
Kawasaki Kanagawa
Boehringer Ingelheim Investigational Site 184
Kawasaki Kanagawa
Boehringer Ingelheim Investigational Site 185
Kawasaki Kanagawa
Boehringer Ingelheim Investigational Site 186
Kawasaki Kanagawa
Boehringer Ingelheim Investigational Site 42
Kesennuma Miyagi
Boehringer Ingelheim Investigational Site 129
Kisarazu Chiba
Boehringer Ingelheim Investigational Site 325
Kishiwada Osaka
Boehringer Ingelheim Investigational Site 326
Kishiwada Osaka
Boehringer Ingelheim Investigational Site 377
Kita Kagawa
Boehringer Ingelheim Investigational Site 110
Kitaadachi Saitama
Boehringer Ingelheim Investigational Site 387
Kitakyushu Fukuoka
Boehringer Ingelheim Investigational Site 388
Kitakyushu Fukuoka
Boehringer Ingelheim Investigational Site 389
Kitakyushu Fukuoka
Boehringer Ingelheim Investigational Site 390
Kitakyushu Fukuoka
Boehringer Ingelheim Investigational Site 391
Kitakyushu Fukuoka
Boehringer Ingelheim Investigational Site 392
Kitakyushu Fukuoka
Boehringer Ingelheim Investigational Site 25
Kitami Hokkaido
Boehringer Ingelheim Investigational Site 26
Kitami Hokkaido
Boehringer Ingelheim Investigational Site 180
Kiyose Tokyo
Boehringer Ingelheim Investigational Site 181
Kiyose Tokyo
Boehringer Ingelheim Investigational Site 327
Kobe Hyogo
Boehringer Ingelheim Investigational Site 328
Kobe Hyogo
Boehringer Ingelheim Investigational Site 329
Kobe Hyogo
Boehringer Ingelheim Investigational Site 330
Kobe Hyogo
Boehringer Ingelheim Investigational Site 331
Kobe Hyogo
Boehringer Ingelheim Investigational Site 383
Kochi Kochi
Boehringer Ingelheim Investigational Site 384
Kochi Kochi
Boehringer Ingelheim Investigational Site 385
Kochi Kochi
Boehringer Ingelheim Investigational Site 386
Kochi Kochi
Boehringer Ingelheim Investigational Site 174
Kodaira Tokyo
Boehringer Ingelheim Investigational Site 233
Kofu Yamanashi
Boehringer Ingelheim Investigational Site 397
Koga Fukuoka
Boehringer Ingelheim Investigational Site 398
Koga Fukuoka
Boehringer Ingelheim Investigational Site 179
Komae Tokyo
Boehringer Ingelheim Investigational Site 228
Komatsu Ishikawa
Boehringer Ingelheim Investigational Site 61
Koriyama Fukushima
Boehringer Ingelheim Investigational Site 62
Koriyama Fukushima
Boehringer Ingelheim Investigational Site 63
Koriyama Fukushima
Boehringer Ingelheim Investigational Site 103
Koshigaya Saitama
Boehringer Ingelheim Investigational Site 149
Koto Tokyo
Boehringer Ingelheim Investigational Site 150
Koto Tokyo
Boehringer Ingelheim Investigational Site 108
Kumagaya Saitama
Boehringer Ingelheim Investigational Site 109
Kumagaya Saitama
Boehringer Ingelheim Investigational Site 411
Kumamoto Kumamoto
Boehringer Ingelheim Investigational Site 413
Kumamoto Kumamoto
Boehringer Ingelheim Investigational Site 414
Kumamoto Kumamoto
Boehringer Ingelheim Investigational Site 415
Kumamoto Kumamoto
Boehringer Ingelheim Investigational Site 352
Kurashiki Okayama
Boehringer Ingelheim Investigational Site 355
Kurashiki Okayama
Boehringer Ingelheim Investigational Site 365
Kure Hiroshima
Boehringer Ingelheim Investigational Site 366
Kure Hiroshima
Boehringer Ingelheim Investigational Site 24
Kushiro
Boehringer Ingelheim Investigational Site 278
Kuwana Mie
Boehringer Ingelheim Investigational Site 285
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 286
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 287
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 288
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 291
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 292
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 293
Kyoto Kyoto
Boehringer Ingelheim Investigational Site 177
Machida Tokyo
Boehringer Ingelheim Investigational Site 91
Maebashi Gumma
Boehringer Ingelheim Investigational Site 92
Maebashi Gumma
Boehringer Ingelheim Investigational Site 93
Maebashi Gumma
Boehringer Ingelheim Investigational Site 94
Maebashi Gumma
Boehringer Ingelheim Investigational Site 119
Matsudo Chiba
Boehringer Ingelheim Investigational Site 346
Matsue Shimane
Boehringer Ingelheim Investigational Site 347
Matsue Shimane
Boehringer Ingelheim Investigational Site 241
Matsumoto Nagano
Boehringer Ingelheim Investigational Site 242
Matsumoto Nagano
Boehringer Ingelheim Investigational Site 243
Matsumoto Nagano
Boehringer Ingelheim Investigational Site 244
Matsumoto Nagano
Boehringer Ingelheim Investigational Site 249
Matsumoto Nagano
Boehringer Ingelheim Investigational Site 250
Matsumoto Nagano
Boehringer Ingelheim Investigational Site 280
Matsusaka Mie
Boehringer Ingelheim Investigational Site 378
Matsuyama Ehime
Boehringer Ingelheim Investigational Site 379
Matsuyama Ehime
Boehringer Ingelheim Investigational Site 381
Matsuyama Ehime
Boehringer Ingelheim Investigational Site 158
Meguro Tokyo
Boehringer Ingelheim Investigational Site 159
Meguro Tokyo
Boehringer Ingelheim Investigational Site 416
Minamata Kumamoto
Boehringer Ingelheim Investigational Site 137
Minato Tokyo
Boehringer Ingelheim Investigational Site 138
Minato Tokyo
Boehringer Ingelheim Investigational Site 139
Minato Tokyo
Boehringer Ingelheim Investigational Site 140
Minato Tokyo
Boehringer Ingelheim Investigational Site 171
Mitaka Tokyo
Boehringer Ingelheim Investigational Site 172
Mitaka Tokyo
Boehringer Ingelheim Investigational Site 75
Mito Ibaraki
Boehringer Ingelheim Investigational Site 419
Miyazaki Miyazaki
Boehringer Ingelheim Investigational Site 420
Miyazaki Miyazaki
Boehringer Ingelheim Investigational Site 421
Miyazaki Miyazaki
Boehringer Ingelheim Investigational Site 315
Moriguchi Osaka
Boehringer Ingelheim Investigational Site 33
Morioka Iwate
Boehringer Ingelheim Investigational Site 34
Morioka Iwate
Boehringer Ingelheim Investigational Site 282
Moriyama Shiga
Boehringer Ingelheim Investigational Site 283
Moriyama Shiga
Boehringer Ingelheim Investigational Site 5
Muroran Hokkaido
Boehringer Ingelheim Investigational Site 284
Nagahama Shiga
Boehringer Ingelheim Investigational Site 274
Nagakute Aichi
Boehringer Ingelheim Investigational Site 236
Nagano Nagano
Boehringer Ingelheim Investigational Site 237
Nagano Nagano
Boehringer Ingelheim Investigational Site 238
Nagano Nagano
Boehringer Ingelheim Investigational Site 210
Nagaoka Niigata
Boehringer Ingelheim Investigational Site 211
Nagaoka Niigata
Boehringer Ingelheim Investigational Site 212
Nagaoka Niigata
Boehringer Ingelheim Investigational Site 405
Nagasaki Nagasaki
Boehringer Ingelheim Investigational Site 406
Nagasaki Nagasaki
Boehringer Ingelheim Investigational Site 267
Nagoya Aichi
Boehringer Ingelheim Investigational Site 268
Nagoya Aichi
Boehringer Ingelheim Investigational Site 269
Nagoya Aichi
Boehringer Ingelheim Investigational Site 270
Nagoya Aichi
Boehringer Ingelheim Investigational Site 271
Nagoya Aichi
Boehringer Ingelheim Investigational Site 272
Nagoya Aichi
Boehringer Ingelheim Investigational Site 80
Naka Ibaraki
Boehringer Ingelheim Investigational Site 167
Nakano Tokyo
Boehringer Ingelheim Investigational Site 341
Nara Nara
Boehringer Ingelheim Investigational Site 122
Narashino Chiba
Boehringer Ingelheim Investigational Site 39
Natori Miyagi
Boehringer Ingelheim Investigational Site 169
Nerima Tokyo
Boehringer Ingelheim Investigational Site 170
Nerima Tokyo
Boehringer Ingelheim Investigational Site 215
Niigata Niigata
Boehringer Ingelheim Investigational Site 216
Niigata Niigata
Boehringer Ingelheim Investigational Site 217
Niigata Niigata
Boehringer Ingelheim Investigational Site 218
Niigata Niigata
Boehringer Ingelheim Investigational Site 382
Niihama Ehime
Boehringer Ingelheim Investigational Site 334
Nishinomiya Hyogo
Boehringer Ingelheim Investigational Site 335
Nishinomiya Hyogo
Boehringer Ingelheim Investigational Site 336
Nishinomiya Hyogo
Boehringer Ingelheim Investigational Site 22
Obihiro Hokkaido
Boehringer Ingelheim Investigational Site 23
Obihiro Hokkaido
Boehringer Ingelheim Investigational Site 253
Ogaki Gifu
Boehringer Ingelheim Investigational Site 417
Oita Oita
Boehringer Ingelheim Investigational Site 418
Oita Oita
Boehringer Ingelheim Investigational Site 350
Okayama Okayama
Boehringer Ingelheim Investigational Site 351
Okayama Okayama
Boehringer Ingelheim Investigational Site 353
Okayama Okayama
Boehringer Ingelheim Investigational Site 264
Okazaki Aichi
Boehringer Ingelheim Investigational Site 265
Okazaki Aichi
Boehringer Ingelheim Investigational Site 178
Ome Tokyo
Boehringer Ingelheim Investigational Site 358
Onomichi Hiroshima
Boehringer Ingelheim Investigational Site 295
Osaka Osaka
Boehringer Ingelheim Investigational Site 296
Osaka Osaka
Boehringer Ingelheim Investigational Site 297
Osaka Osaka
Boehringer Ingelheim Investigational Site 298
Osaka Osaka
Boehringer Ingelheim Investigational Site 299
Osaka Osaka
Boehringer Ingelheim Investigational Site 300
Osaka Osaka
Boehringer Ingelheim Investigational Site 301
Osaka Osaka
Boehringer Ingelheim Investigational Site 302
Osaka Osaka
Boehringer Ingelheim Investigational Site 303
Osaka Osaka
Boehringer Ingelheim Investigational Site 304
Osaka Osaka
Boehringer Ingelheim Investigational Site 305
Osaka Osaka
Boehringer Ingelheim Investigational Site 306
Osaka Osaka
Boehringer Ingelheim Investigational Site 307
Osaka Osaka
Boehringer Ingelheim Investigational Site 43
Osaki Miyagi
Boehringer Ingelheim Investigational Site 35
Oshu Iwate
Boehringer Ingelheim Investigational Site 96
Ota Gumma
Boehringer Ingelheim Investigational Site 153
Ota Tokyo
Boehringer Ingelheim Investigational Site 154
Ota Tokyo
Boehringer Ingelheim Investigational Site 155
Ota Tokyo
Boehringer Ingelheim Investigational Site 156
Ota Tokyo
Boehringer Ingelheim Investigational Site 4
Otaru Hokkaido

Other trials in Japan

About this study

Official title: Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.

In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: Afatinib dimaleate
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.

Afatinib dimaleateDrug
20mg - 50mg

Study groups in NCT02131259
Study group	Role	What they receive
Afatinib		Not described Receives: Drug: Afatinib dimaleate

What is being measured

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

Incidence of Adverse Drug Reactions (ADRs)
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied".
The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
Measured: From first drug administration until 28 days after the last drug administration, up to 52 weeks.

Secondary outcomes (1)

Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor [TKI]-naïve patients and the TKI pre-treated patients.
Overall response was calculated with 95% Clopper-Pearson confidence interval.
OR = (CR+PR)/(CR+PR+SD+PD+Unknown)*100.
Measured: 52 weeks.

Timeline

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

7 May 201428 Dec 2016

First posted6 May 2014 (estimated)
Study start7 May 2014
Primary completion28 Dec 2016
Study completion28 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,605 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02131259
Sponsor's protocol ID: 1200.181
Status last verified: Sep 2018
First submitted: 5 May 2014
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1
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RecruitingPhase 3
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All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT02131259
Acronym / sponsor ID: 1200.181
Conditions: Carcinoma, Non-Small-Cell Lung
Study type: Observational
Recruitment status: Completed
Enrolment: 1,605 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 7 May 2014 (actual)
Primary completion: 28 Dec 2016 (actual)
Study completion: 28 Dec 2016 (actual)
First posted: 6 May 2014 (estimated)
Results: Posted 7 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Afatinib	–	Drug: Afatinib dimaleate

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 1500

Key inclusion criteria (1 listed)

Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Afatinib dimaleate20mg - 50mg	Drug	Afatinib

Primary outcome

Incidence of Adverse Drug Reactions (ADRs)
Time frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.

1 secondary outcome

Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
Time frame: 52 weeks.

Results and safety

Results posted to the registry on 7 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib Dimaleate	1,602	377

Primary outcome: Incidence of Adverse Drug Reactions (ADRs)

Time frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.. Number. Unit: Percentage of Participants

Measure	Afatinib Dimaleate n = 1602
Value	95.19

Population analysed: Safety Set: This analysis set included all patients who had received treatment of GIOTRIF® tablets except those who were found not following registration rules, invalid contract or previous treatment experience with GIOTRIF® tablets.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib Dimaleate	1,129 of 1,602 (70.5%)	1,432 of 1,602 (89.4%)	Not reported

Limitations and caveats (from the sponsor): The general scientific objective of this non-interventional study was to obtain an estimate of occurrence of AEs in the population under study. This study did not include a comparator, hindering the ability to this real world data into perspective.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

432 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 432 sites in Japan.

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 1 inclusion and 1 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 432 sites in Japan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2018). 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?

Incidence of Adverse Drug Reactions (ADRs) (time frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.). 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 NCT02131259.

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 7 Sep 2018.