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)

Launched by BOEHRINGER INGELHEIM · May 13, 2013

Keywords

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Gender

ALL

Eligibility criteria

• 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)