GILOTRIF tablets contain afatinib, a tyrosine
kinase inhibitor which is a 4-anilinoquinazoline.
GILOTRIF is indicated for the first-line treatment
of patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19 deletions
or exon 21 (L858R) substitution mutations as detected by an FDA-approved
test [see Clinical Studies ].
Limitation of Use:
Safety and efficacy of GILOTRIF have not been established in patients
whose tumors have other EGFR mutations [see Clinical Studies].
Published Studies Related to Gilotrif (Afatinib)
Afatinib versus placebo as adjuvant therapy after chemoradiation in a
double-blind, phase III study (LUX-Head & Neck 2) in patients with primary
unresected, clinically intermediate-to-high-risk head and neck cancer: study
protocol for a randomized controlled trial. 
BACKGROUND: Over 50% of patients with head and neck squamous cell carcinoma
(HNSCC) present with locoregionally advanced disease. Those at
intermediate-to-high risk of recurrence after definitive therapy exhibit advanced
disease based on tumour size or lymph node involvement, non-oropharynx primary
sites, human papillomavirus (HPV)-negative oropharyngeal cancer, or HPV-positive
oropharynx cancer with smoking history (>10-pack-years)...
Symptom and quality of life benefit of afatinib in advanced non-small-cell lung
cancer patients previously treated with erlotinib or gefitinib: results of a
randomized phase IIb/III trial (LUX-Lung 1). 
in a double-blind, randomized, phase IIb/III trial (LUX-Lung 1)... CONCLUSION: In the LUX-Lung 1 trial, the addition of afatinib to BSC
Afatinib versus placebo for patients with advanced, metastatic non-small-cell
lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines
of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. 
tyrosine-kinase inhibitors... INTERPRETATION: Although we recorded no benefit in terms of overall survival with
A randomised, open-label phase II trial of afatinib versus cetuximab in patients
with metastatic colorectal cancer. 
mutations was also evaluated... CONCLUSIONS: The efficacy of afatinib was inferior to cetuximab in patients with
Is progression-free survival associated with a better health-related quality of
life in patients with lung cancer? Evidence from two randomised trials with
evaluated in two randomised trials... CONCLUSIONS: Tumour progression in patients with NSCLC was associated with
Clinical Trials Related to Gilotrif (Afatinib)
Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance
therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2
every 3 weeks)in squamous cell carcinoma of the head and neck.
The Safety and Efficacy Study of Afatinib (CT) Compared With Afatinib (GIOTRIF) in Patients With Solid Tumors (Including Mutations Identified EGFR) [Active, not recruiting]
Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients [Recruiting]
Safety Study of Afatinib for Brain Cancer [Not yet recruiting]
The purpose of this study is to try to determine the maximum safe dose of afatinib that can
be administered to people with brain cancer. Other purposes of this study are to:
- find out what effects (good and bad) afatinib has;
- see how much drug gets into the body by collecting blood and cerebrospinal fluid for
use in pharmacokinetic (PK) studies;
- learn more about how afatinib might affect the growth of cancer cells;
- look at biomarkers (biochemical features that can be used to measure the progress of
disease or the effects of a drug).
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 [Completed]
The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day
(i. e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine
the recommended dose for the Phase II step.
The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in
patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose
determined in the Phase I step.