This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatment afatinib
Phase phase 3
Targets EGFR, HER2, HER4
Sponsor Boehringer Ingelheim
Start date July 2013
End date January 2017
Trial size 481 participants
Trial identifier NCT01853826, 1200.55, 2009-017661-34


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will receive afatinib once daily
Patients will receive afatinib once daily

Primary Outcomes

Adverse Events according to Common Terminology Criteria (CTCAE Version 3)
time frame: up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.