NCT00711594 - LUX-Lung 4: BIBW 2992 (Afatinib) Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

BIBW 2992 MA2 40mg/day

Phase I step: Increased dose cohorts from low dose to MTD

DRUG

BIBW 2992 MA2 50mg/day

Phase I step: Increased dose cohorts from low dose to MTD

DRUG

BIBW 2992 MA2 20mg/day

Phase I step: Increased dose cohorts from low dose to MTD

DRUG

BIBW 2992 QD

Phase II step: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs.

Trial Locations (20)

1200.33.010 Boehringer Ingelheim Investigational Site, Akashi, Hyogo

1200.33.001 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo

1200.33.007 Boehringer Ingelheim Investigational Site, Fukuoka, Fukuoka

1200.33.013 Boehringer Ingelheim Investigational Site, Hidaka, Saitama

1200.33.011 Boehringer Ingelheim Investigational Site, Kanazawa, Ishikawa

1200.33.003 Boehringer Ingelheim Investigational Site, Kashiwa, Chiba

1200.33.019 Boehringer Ingelheim Investigational Site, Kobe, Hyogo

1200.33.008 Boehringer Ingelheim Investigational Site, Koto-ku, Tokyo

1200.33.020 Boehringer Ingelheim Investigational Site, Matsuyama, Ehime

1200.33.006 Boehringer Ingelheim Investigational Site, Miyakojima-ku, Osaka

1200.33.004 Boehringer Ingelheim Investigational Site, Nagoya, Aichi

1200.33.017 Boehringer Ingelheim Investigational Site, Nagoya, Aichi

1200.33.016 Boehringer Ingelheim Investigational Site, Niigata, Niigata

1200.33.009 Boehringer Ingelheim Investigational Site, Okayama, Okayama

1200.33.005 Boehringer Ingelheim Investigational Site, Osaka-Sayama, Osaka

1200.33.018 Boehringer Ingelheim Investigational Site, Sakai, Osaka

1200.33.015 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido

1200.33.012 Boehringer Ingelheim Investigational Site, Sendai, Miyagi

1200.33.002 Boehringer Ingelheim Investigational Site, Sunto-gun, Shizuoka

1200.33.014 Boehringer Ingelheim Investigational Site, Yufu, Oita