Status:
COMPLETED
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)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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).
- Platelet count \>75,000/mm3
- Serum creatinine \< 1.5 times of the upper limit of normal
- 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).
- 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:
- Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- 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)
Exclusion
Key Trial Info
Start Date :
July 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT01853826
Start Date
July 17 2013
End Date
March 6 2024
Last Update
April 11 2025
Active Locations (118)
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1
The Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
2
Sunshine Hospital
AT Albans, Victoria, Australia, 3021
3
St John of God Murdoch
Murdoch, Western Australia, Australia, 6150
4
Medical University of Graz State Hospital - University Hospital Graz
Graz, Austria, 8036