Long-term Observation PMS for Afatinib

September 6, 2018 updated by: Boehringer Ingelheim

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).

Study Overview

Status

Completed

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

Drug: Afatinib dimaleate

Study Type

Observational

Enrollment (Actual)

1605

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

Japan
- - Adachi Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 145
  - Aira Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 429
  - Aizuwakamatsu Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 64
  - Akita Akita, Japan
    - Boehringer Ingelheim Investigational Site 44
  - Akita Akita, Japan
    - Boehringer Ingelheim Investigational Site 45
  - Akita Akita, Japan
    - Boehringer Ingelheim Investigational Site 46
  - Akita Akita, Japan
    - Boehringer Ingelheim Investigational Site 47
  - Amagasaki Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 333
  - Anjo Aichi, Japan
    - Boehringer Ingelheim Investigational Site 266
  - Aomori Aomori, Japan
    - Boehringer Ingelheim Investigational Site 27
  - Aomori Aomori, Japan
    - Boehringer Ingelheim Investigational Site 28
  - Asahi Chiba, Japan
    - Boehringer Ingelheim Investigational Site 127
  - Asahi Chiba, Japan
    - Boehringer Ingelheim Investigational Site 128
  - Asahikawa Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 18
  - Asahikawa Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 19
  - Asahikawa Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 20
  - Asahikawa Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 21
  - Atsugi Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 198
  - Ayabe Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 294
  - Bunkyo Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 142
  - Bunkyo Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 143
  - Bunkyo Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 144
  - Chiba Chiba, Japan
    - Boehringer Ingelheim Investigational Site 112
  - Chiba Chiba, Japan
    - Boehringer Ingelheim Investigational Site 113
  - Chiba Chiba, Japan
    - Boehringer Ingelheim Investigational Site 114
  - Chiba Chiba, Japan
    - Boehringer Ingelheim Investigational Site 115
  - Chiba Chiba, Japan
    - Boehringer Ingelheim Investigational Site 116
  - Chiba Chiba, Japan
    - Boehringer Ingelheim Investigational Site 117
  - Chikugo Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 402
  - Chitose Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 16
  - Chiyoda Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 132
  - Chiyoda Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 133
  - Chiyoda Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 134
  - Chuo Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 135
  - Chuo Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 136
  - Chuo Yamanashi, Japan
    - Boehringer Ingelheim Investigational Site 234
  - Chuo Yamanashi, Japan
    - Boehringer Ingelheim Investigational Site 235
  - Daisen Akita, Japan
    - Boehringer Ingelheim Investigational Site 48
  - Edogawa Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 147
  - Edogawa Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 148
  - Fuchu Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 173
  - Fuji Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 257
  - Fujieda Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 260
  - Fujioka Gumma, Japan
    - Boehringer Ingelheim Investigational Site 97
  - Fujisawa Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 203
  - Fukaya Saitama, Japan
    - Boehringer Ingelheim Investigational Site 111
  - Fukui Fukui, Japan
    - Boehringer Ingelheim Investigational Site 231
  - Fukui Fukui, Japan
    - Boehringer Ingelheim Investigational Site 232
  - Fukuoka Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 393
  - Fukuoka Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 394
  - Fukuoka Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 395
  - Fukuoka Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 396
  - Fukuoka Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 399
  - Fukushima Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 58
  - Fukushima Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 59
  - Fukushima Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 60
  - Fukuyama Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 356
  - Fukuyama Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 357
  - Funabashi Chiba, Japan
    - Boehringer Ingelheim Investigational Site 121
  - Gifu Gifu, Japan
    - Boehringer Ingelheim Investigational Site 251
  - Gifu Gifu, Japan
    - Boehringer Ingelheim Investigational Site 252
  - Ginowan Okinawa, Japan
    - Boehringer Ingelheim Investigational Site 432
  - Habikino Osaka, Japan
    - Boehringer Ingelheim Investigational Site 321
  - Hachinohe Aomori, Japan
    - Boehringer Ingelheim Investigational Site 29
  - Hachinohe Aomori, Japan
    - Boehringer Ingelheim Investigational Site 30
  - Hachioji Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 176
  - Hadano Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 209
  - Hakodate Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 3
  - Hamada Shimane, Japan
    - Boehringer Ingelheim Investigational Site 349
  - Hamamatsu Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 261
  - Hatsukaichi Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 367
  - Hidaka Saitama, Japan
    - Boehringer Ingelheim Investigational Site 107
  - Higashiibaraki Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 76
  - Higashiokitama Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 53
  - Higashiokitama Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 54
  - Higashiosaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 318
  - Himeji Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 339
  - Hirakata Osaka, Japan
    - Boehringer Ingelheim Investigational Site 316
  - Hirakata Osaka, Japan
    - Boehringer Ingelheim Investigational Site 317
  - Hiratsuka Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 208
  - Hirosaki Aomori, Japan
    - Boehringer Ingelheim Investigational Site 31
  - Hirosaki Aomori, Japan
    - Boehringer Ingelheim Investigational Site 32
  - Hiroshima Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 359
  - Hiroshima Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 360
  - Hiroshima Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 361
  - Hiroshima Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 362
  - Hiroshima Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 363
  - Hiroshima Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 364
  - Hitachi Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 79
  - Hitachinaka Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 77
  - Hitachinaka Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 78
  - Ibaraki Osaka, Japan
    - Boehringer Ingelheim Investigational Site 312
  - Ichihara Chiba, Japan
    - Boehringer Ingelheim Investigational Site 131
  - Ichikawa Chiba, Japan
    - Boehringer Ingelheim Investigational Site 120
  - Iida Nagano, Japan
    - Boehringer Ingelheim Investigational Site 246
  - Iida Nagano, Japan
    - Boehringer Ingelheim Investigational Site 247
  - Ikeda Osaka, Japan
    - Boehringer Ingelheim Investigational Site 309
  - Ina Nagano, Japan
    - Boehringer Ingelheim Investigational Site 248
  - Inzai Chiba, Japan
    - Boehringer Ingelheim Investigational Site 118
  - Iruma Saitama, Japan
    - Boehringer Ingelheim Investigational Site 105
  - Isa Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 428
  - Isahaya Nagasaki, Japan
    - Boehringer Ingelheim Investigational Site 407
  - Ise Mie, Japan
    - Boehringer Ingelheim Investigational Site 281
  - Isesaki Gumma, Japan
    - Boehringer Ingelheim Investigational Site 95
  - Itabashi Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 168
  - Iwaki Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 65
  - Iwakuni Yamaguchi, Japan
    - Boehringer Ingelheim Investigational Site 368
  - Iwamizawa Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 17
  - Izumi Osaka, Japan
    - Boehringer Ingelheim Investigational Site 324
  - Izumo Shimane, Japan
    - Boehringer Ingelheim Investigational Site 348
  - Izunokuni Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 255
  - Joetsu Niigata, Japan
    - Boehringer Ingelheim Investigational Site 213
  - Joetsu Niigata, Japan
    - Boehringer Ingelheim Investigational Site 214
  - Joyo Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 289
  - Kagoshima Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 422
  - Kagoshima Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 423
  - Kagoshima Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 424
  - Kagoshima Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 425
  - Kagoshima Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 426
  - Kakegawa Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 262
  - Kakogawa Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 340
  - Kamakura Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 201
  - Kamakura Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 202
  - Kamogawa Chiba, Japan
    - Boehringer Ingelheim Investigational Site 130
  - Kanazawa Ishikawa, Japan
    - Boehringer Ingelheim Investigational Site 223
  - Kanazawa Ishikawa, Japan
    - Boehringer Ingelheim Investigational Site 224
  - Kanazawa Ishikawa, Japan
    - Boehringer Ingelheim Investigational Site 225
  - Kanazawa Ishikawa, Japan
    - Boehringer Ingelheim Investigational Site 226
  - Kanazawa Ishikawa, Japan
    - Boehringer Ingelheim Investigational Site 227
  - Kasama Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 74
  - Kashihara Nara, Japan
    - Boehringer Ingelheim Investigational Site 343
  - Kashiwa Chiba, Japan
    - Boehringer Ingelheim Investigational Site 123
  - Kashiwa Chiba, Japan
    - Boehringer Ingelheim Investigational Site 124
  - Kashiwa Chiba, Japan
    - Boehringer Ingelheim Investigational Site 125
  - Kasukabe Saitama, Japan
    - Boehringer Ingelheim Investigational Site 104
  - Kawagoe Saitama, Japan
    - Boehringer Ingelheim Investigational Site 106
  - Kawaguchi Saitama, Japan
    - Boehringer Ingelheim Investigational Site 100
  - Kawaguchi Saitama, Japan
    - Boehringer Ingelheim Investigational Site 99
  - Kawasaki Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 182
  - Kawasaki Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 183
  - Kawasaki Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 184
  - Kawasaki Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 185
  - Kawasaki Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 186
  - Kesennuma Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 42
  - Kisarazu Chiba, Japan
    - Boehringer Ingelheim Investigational Site 129
  - Kishiwada Osaka, Japan
    - Boehringer Ingelheim Investigational Site 325
  - Kishiwada Osaka, Japan
    - Boehringer Ingelheim Investigational Site 326
  - Kita Kagawa, Japan
    - Boehringer Ingelheim Investigational Site 377
  - Kitaadachi Saitama, Japan
    - Boehringer Ingelheim Investigational Site 110
  - Kitakyushu Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 387
  - Kitakyushu Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 388
  - Kitakyushu Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 389
  - Kitakyushu Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 390
  - Kitakyushu Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 391
  - Kitakyushu Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 392
  - Kitami Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 25
  - Kitami Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 26
  - Kiyose Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 180
  - Kiyose Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 181
  - Kobe Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 327
  - Kobe Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 328
  - Kobe Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 329
  - Kobe Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 330
  - Kobe Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 331
  - Kochi Kochi, Japan
    - Boehringer Ingelheim Investigational Site 383
  - Kochi Kochi, Japan
    - Boehringer Ingelheim Investigational Site 384
  - Kochi Kochi, Japan
    - Boehringer Ingelheim Investigational Site 385
  - Kochi Kochi, Japan
    - Boehringer Ingelheim Investigational Site 386
  - Kodaira Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 174
  - Kofu Yamanashi, Japan
    - Boehringer Ingelheim Investigational Site 233
  - Koga Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 397
  - Koga Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 398
  - Komae Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 179
  - Komatsu Ishikawa, Japan
    - Boehringer Ingelheim Investigational Site 228
  - Koriyama Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 61
  - Koriyama Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 62
  - Koriyama Fukushima, Japan
    - Boehringer Ingelheim Investigational Site 63
  - Koshigaya Saitama, Japan
    - Boehringer Ingelheim Investigational Site 103
  - Koto Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 149
  - Koto Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 150
  - Kumagaya Saitama, Japan
    - Boehringer Ingelheim Investigational Site 108
  - Kumagaya Saitama, Japan
    - Boehringer Ingelheim Investigational Site 109
  - Kumamoto Kumamoto, Japan
    - Boehringer Ingelheim Investigational Site 411
  - Kumamoto Kumamoto, Japan
    - Boehringer Ingelheim Investigational Site 413
  - Kumamoto Kumamoto, Japan
    - Boehringer Ingelheim Investigational Site 414
  - Kumamoto Kumamoto, Japan
    - Boehringer Ingelheim Investigational Site 415
  - Kurashiki Okayama, Japan
    - Boehringer Ingelheim Investigational Site 352
  - Kurashiki Okayama, Japan
    - Boehringer Ingelheim Investigational Site 355
  - Kure Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 365
  - Kure Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 366
  - Kushiro Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 24
  - Kuwana Mie, Japan
    - Boehringer Ingelheim Investigational Site 278
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 285
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 286
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 287
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 288
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 291
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 292
  - Kyoto Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 293
  - Machida Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 177
  - Maebashi Gumma, Japan
    - Boehringer Ingelheim Investigational Site 91
  - Maebashi Gumma, Japan
    - Boehringer Ingelheim Investigational Site 92
  - Maebashi Gumma, Japan
    - Boehringer Ingelheim Investigational Site 93
  - Maebashi Gumma, Japan
    - Boehringer Ingelheim Investigational Site 94
  - Matsudo Chiba, Japan
    - Boehringer Ingelheim Investigational Site 119
  - Matsue Shimane, Japan
    - Boehringer Ingelheim Investigational Site 346
  - Matsue Shimane, Japan
    - Boehringer Ingelheim Investigational Site 347
  - Matsumoto Nagano, Japan
    - Boehringer Ingelheim Investigational Site 241
  - Matsumoto Nagano, Japan
    - Boehringer Ingelheim Investigational Site 242
  - Matsumoto Nagano, Japan
    - Boehringer Ingelheim Investigational Site 243
  - Matsumoto Nagano, Japan
    - Boehringer Ingelheim Investigational Site 244
  - Matsumoto Nagano, Japan
    - Boehringer Ingelheim Investigational Site 249
  - Matsumoto Nagano, Japan
    - Boehringer Ingelheim Investigational Site 250
  - Matsusaka Mie, Japan
    - Boehringer Ingelheim Investigational Site 280
  - Matsuyama Ehime, Japan
    - Boehringer Ingelheim Investigational Site 378
  - Matsuyama Ehime, Japan
    - Boehringer Ingelheim Investigational Site 379
  - Matsuyama Ehime, Japan
    - Boehringer Ingelheim Investigational Site 381
  - Meguro Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 158
  - Meguro Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 159
  - Minamata Kumamoto, Japan
    - Boehringer Ingelheim Investigational Site 416
  - Minato Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 137
  - Minato Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 138
  - Minato Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 139
  - Minato Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 140
  - Mitaka Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 171
  - Mitaka Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 172
  - Mito Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 75
  - Miyazaki Miyazaki, Japan
    - Boehringer Ingelheim Investigational Site 419
  - Miyazaki Miyazaki, Japan
    - Boehringer Ingelheim Investigational Site 420
  - Miyazaki Miyazaki, Japan
    - Boehringer Ingelheim Investigational Site 421
  - Moriguchi Osaka, Japan
    - Boehringer Ingelheim Investigational Site 315
  - Morioka Iwate, Japan
    - Boehringer Ingelheim Investigational Site 33
  - Morioka Iwate, Japan
    - Boehringer Ingelheim Investigational Site 34
  - Moriyama Shiga, Japan
    - Boehringer Ingelheim Investigational Site 282
  - Moriyama Shiga, Japan
    - Boehringer Ingelheim Investigational Site 283
  - Muroran Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 5
  - Nagahama Shiga, Japan
    - Boehringer Ingelheim Investigational Site 284
  - Nagakute Aichi, Japan
    - Boehringer Ingelheim Investigational Site 274
  - Nagano Nagano, Japan
    - Boehringer Ingelheim Investigational Site 236
  - Nagano Nagano, Japan
    - Boehringer Ingelheim Investigational Site 237
  - Nagano Nagano, Japan
    - Boehringer Ingelheim Investigational Site 238
  - Nagaoka Niigata, Japan
    - Boehringer Ingelheim Investigational Site 210
  - Nagaoka Niigata, Japan
    - Boehringer Ingelheim Investigational Site 211
  - Nagaoka Niigata, Japan
    - Boehringer Ingelheim Investigational Site 212
  - Nagasaki Nagasaki, Japan
    - Boehringer Ingelheim Investigational Site 405
  - Nagasaki Nagasaki, Japan
    - Boehringer Ingelheim Investigational Site 406
  - Nagoya Aichi, Japan
    - Boehringer Ingelheim Investigational Site 267
  - Nagoya Aichi, Japan
    - Boehringer Ingelheim Investigational Site 268
  - Nagoya Aichi, Japan
    - Boehringer Ingelheim Investigational Site 269
  - Nagoya Aichi, Japan
    - Boehringer Ingelheim Investigational Site 270
  - Nagoya Aichi, Japan
    - Boehringer Ingelheim Investigational Site 271
  - Nagoya Aichi, Japan
    - Boehringer Ingelheim Investigational Site 272
  - Naka Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 80
  - Nakano Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 167
  - Nara Nara, Japan
    - Boehringer Ingelheim Investigational Site 341
  - Narashino Chiba, Japan
    - Boehringer Ingelheim Investigational Site 122
  - Natori Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 39
  - Nerima Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 169
  - Nerima Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 170
  - Niigata Niigata, Japan
    - Boehringer Ingelheim Investigational Site 215
  - Niigata Niigata, Japan
    - Boehringer Ingelheim Investigational Site 216
  - Niigata Niigata, Japan
    - Boehringer Ingelheim Investigational Site 217
  - Niigata Niigata, Japan
    - Boehringer Ingelheim Investigational Site 218
  - Niihama Ehime, Japan
    - Boehringer Ingelheim Investigational Site 382
  - Nishinomiya Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 334
  - Nishinomiya Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 335
  - Nishinomiya Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 336
  - Obihiro Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 22
  - Obihiro Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 23
  - Ogaki Gifu, Japan
    - Boehringer Ingelheim Investigational Site 253
  - Oita Oita, Japan
    - Boehringer Ingelheim Investigational Site 417
  - Oita Oita, Japan
    - Boehringer Ingelheim Investigational Site 418
  - Okayama Okayama, Japan
    - Boehringer Ingelheim Investigational Site 350
  - Okayama Okayama, Japan
    - Boehringer Ingelheim Investigational Site 351
  - Okayama Okayama, Japan
    - Boehringer Ingelheim Investigational Site 353
  - Okazaki Aichi, Japan
    - Boehringer Ingelheim Investigational Site 264
  - Okazaki Aichi, Japan
    - Boehringer Ingelheim Investigational Site 265
  - Ome Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 178
  - Onomichi Hiroshima, Japan
    - Boehringer Ingelheim Investigational Site 358
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 295
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 296
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 297
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 298
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 299
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 300
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 301
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 302
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 303
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 304
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 305
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 306
  - Osaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 307
  - Osaki Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 43
  - Oshu Iwate, Japan
    - Boehringer Ingelheim Investigational Site 35
  - Ota Gumma, Japan
    - Boehringer Ingelheim Investigational Site 96
  - Ota Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 153
  - Ota Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 154
  - Ota Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 155
  - Ota Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 156
  - Otaru Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 4
  - Otawara Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 85
  - Ryugasaki Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 70
  - Saga Saga, Japan
    - Boehringer Ingelheim Investigational Site 403
  - Sagamihara Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 204
  - Sagamihara Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 205
  - Sagamihara Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 206
  - Sagamihara Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 207
  - Sakai Osaka, Japan
    - Boehringer Ingelheim Investigational Site 322
  - Sakai Osaka, Japan
    - Boehringer Ingelheim Investigational Site 323
  - Sakata Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 56
  - Sakata Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 57
  - Saku Nagano, Japan
    - Boehringer Ingelheim Investigational Site 239
  - Sakura Chiba, Japan
    - Boehringer Ingelheim Investigational Site 126
  - Sanda Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 338
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 10
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 11
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 12
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 13
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 14
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 15
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 1
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 2
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 7
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 8
  - Sapporo Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 9
  - Sasebo Nagasaki, Japan
    - Boehringer Ingelheim Investigational Site 409
  - Sasebo Nagasaki, Japan
    - Boehringer Ingelheim Investigational Site 410
  - Sashima Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 73
  - Satsumasendai Kagoshima, Japan
    - Boehringer Ingelheim Investigational Site 427
  - Sendai Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 36
  - Sendai Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 37
  - Sendai Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 38
  - Sendai Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 40
  - Seto Aichi, Japan
    - Boehringer Ingelheim Investigational Site 275
  - Shibata Niigata, Japan
    - Boehringer Ingelheim Investigational Site 219
  - Shibukawa Gumma, Japan
    - Boehringer Ingelheim Investigational Site 98
  - Shibuya Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 157
  - Shimabara Nagasaki, Japan
    - Boehringer Ingelheim Investigational Site 408
  - Shimajiri Okinawa, Japan
    - Boehringer Ingelheim Investigational Site 430
  - Shimonoseki Yamaguchi, Japan
    - Boehringer Ingelheim Investigational Site 369
  - Shimonoseki Yamaguchi, Japan
    - Boehringer Ingelheim Investigational Site 371
  - Shimonoseki Yamaguchi, Japan
    - Boehringer Ingelheim Investigational Site 372
  - Shimotsuga Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 83
  - Shimotsuga Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 84
  - Shimotsuke Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 87
  - Shimotsuke Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 88
  - Shinagawa Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 151
  - Shinagawa Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 152
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 160
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 161
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 162
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 163
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 164
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 165
  - Shinjuku Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 166
  - Shiogama Miyagi, Japan
    - Boehringer Ingelheim Investigational Site 41
  - Shizuoka Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 258
  - Shizuoka Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 259
  - Soka Saitama, Japan
    - Boehringer Ingelheim Investigational Site 102
  - Suita Osaka, Japan
    - Boehringer Ingelheim Investigational Site 310
  - Suita Osaka, Japan
    - Boehringer Ingelheim Investigational Site 311
  - Sumida Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 146
  - Sumoto Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 332
  - Sunto Shizuoka, Japan
    - Boehringer Ingelheim Investigational Site 256
  - Suwa Nagano, Japan
    - Boehringer Ingelheim Investigational Site 245
  - Tachikawa Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 175
  - Taito Tokyo, Japan
    - Boehringer Ingelheim Investigational Site 141
  - Takamatsu Kagawa, Japan
    - Boehringer Ingelheim Investigational Site 376
  - Takaoka Toyama, Japan
    - Boehringer Ingelheim Investigational Site 222
  - Takarazuka Hyogo, Japan
    - Boehringer Ingelheim Investigational Site 337
  - Takasaki Gumma, Japan
    - Boehringer Ingelheim Investigational Site 89
  - Takasaki Gumma, Japan
    - Boehringer Ingelheim Investigational Site 90
  - Takatsuki Osaka, Japan
    - Boehringer Ingelheim Investigational Site 313
  - Takatsuki Osaka, Japan
    - Boehringer Ingelheim Investigational Site 314
  - Takayama Gifu, Japan
    - Boehringer Ingelheim Investigational Site 254
  - Tenri Nara, Japan
    - Boehringer Ingelheim Investigational Site 342
  - Tochigi Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 86
  - Toda Saitama, Japan
    - Boehringer Ingelheim Investigational Site 101
  - Tokushima Tokushima, Japan
    - Boehringer Ingelheim Investigational Site 373
  - Tokushima Tokushima, Japan
    - Boehringer Ingelheim Investigational Site 374
  - Tokushima Tokushima, Japan
    - Boehringer Ingelheim Investigational Site 375
  - Tomakomai Hokkaido, Japan
    - Boehringer Ingelheim Investigational Site 6
  - Toon Ehime, Japan
    - Boehringer Ingelheim Investigational Site 380
  - Toride Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 71
  - Toyama Toyama, Japan
    - Boehringer Ingelheim Investigational Site 220
  - Toyama Toyama, Japan
    - Boehringer Ingelheim Investigational Site 221
  - Toyohashi Aichi, Japan
    - Boehringer Ingelheim Investigational Site 263
  - Toyonaka Osaka, Japan
    - Boehringer Ingelheim Investigational Site 308
  - Toyota Aichi, Japan
    - Boehringer Ingelheim Investigational Site 273
  - Tsu Mie, Japan
    - Boehringer Ingelheim Investigational Site 279
  - Tsuchiura Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 66
  - Tsuchiura Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 67
  - Tsuchiura Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 68
  - Tsukuba Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 69
  - Tsukuba Ibaraki, Japan
    - Boehringer Ingelheim Investigational Site 72
  - Tsuruoka Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 55
  - Tsuyama Okayama, Japan
    - Boehringer Ingelheim Investigational Site 354
  - Ube Yamaguchi, Japan
    - Boehringer Ingelheim Investigational Site 370
  - Ueda Nagano, Japan
    - Boehringer Ingelheim Investigational Site 240
  - Uji Kyoto, Japan
    - Boehringer Ingelheim Investigational Site 290
  - Urasoe Okinawa, Japan
    - Boehringer Ingelheim Investigational Site 431
  - Ureshino Saga, Japan
    - Boehringer Ingelheim Investigational Site 404
  - Utsunomiya Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 81
  - Utsunomiya Tochigi, Japan
    - Boehringer Ingelheim Investigational Site 82
  - Wakayama Wakayama, Japan
    - Boehringer Ingelheim Investigational Site 344
  - Yamaga Kumamoto, Japan
    - Boehringer Ingelheim Investigational Site 412
  - Yamagata Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 49
  - Yamagata Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 50
  - Yamagata Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 51
  - Yamagata Yamagata, Japan
    - Boehringer Ingelheim Investigational Site 52
  - Yamato Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 197
  - Yanagawa Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 401
  - Yao Osaka, Japan
    - Boehringer Ingelheim Investigational Site 319
  - Yao Osaka, Japan
    - Boehringer Ingelheim Investigational Site 320
  - Yokkaichi Mie, Japan
    - Boehringer Ingelheim Investigational Site 276
  - Yokkaichi Mie, Japan
    - Boehringer Ingelheim Investigational Site 277
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 187
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 188
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 189
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 190
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 191
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 194
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 195
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 196
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 199
  - Yokohama Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 200
  - Yokosuka Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 192
  - Yokosuka Kanagawa, Japan
    - Boehringer Ingelheim Investigational Site 193
  - Yonago Tottori, Japan
    - Boehringer Ingelheim Investigational Site 345
  - Yoshida Fukui, Japan
    - Boehringer Ingelheim Investigational Site 229
  - Yoshida Fukui, Japan
    - Boehringer Ingelheim Investigational Site 230
  - Yukuhashi Fukuoka, Japan
    - Boehringer Ingelheim Investigational Site 400

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

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1500

Description

Inclusion criteria:

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

Exclusion criteria:

- None

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Afatinib	Drug: Afatinib dimaleate 20mg - 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first drug administration until 28 days after the last drug administration, up to 52 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

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

Related Info

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)

May 7, 2014

Primary Completion (ACTUAL)

December 28, 2016

Study Completion (ACTUAL)

December 28, 2016

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (ESTIMATE)

May 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1200.181

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Afatinib dimaleate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations