Single arm trial with afatinib to assess its safety in patients with non-small cell lung cancer(NSCLC)harboring EGFR mutation(s)
- Conditions
- Health Condition 1: null- Locally Advanced or Metastatic Non small cell lung cancer
- Registration Number
- CTRI/2014/08/004907
- Lead Sponsor
- Boehringer Ingelheim Hongkong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
-presence of Epidermal Growth Factor Receptor (EGFR) mutation in tumour biopsy.
Results of EGFR mutation must be available before enrolment in this trial. No
rebiopsy is required for purpose of this trial.
-male or female patients age greater than or equal to 18 years and less than or equal to 75 years
-adequate organ function, defined as all of the following:
-Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal values
-Absolute Neutrophil Count (ANC) greater than 1500/mm3. (ANC greater than 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 greater than 75,000/mm3
- Serum creatinine less than 1.5 times of the upper limit of normal
- Total Bilirubin less than 1.5 times upper limit of (institutional) normal (Patients with Gilbertâ??s syndrome total bilirubin must be less than 4 times institutional upper limit of normal)
- Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) less than three times the upper limit of (institutional) normal (ULN) (if related to liver metastases less than five times ULN)
-ECOG score between 0 â?? 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.
-prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
- hormonal 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
- major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical proceduring including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS)
- known hypersensitivity to afatinib or any of its excipients
- history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of greater than 3 (Refer to Appendix 10.2), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within
6 months prior to starting trial treatment.
- Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential described in Section 4.2.3.
Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.
childbearing potential (see Section 4.2.3) who:
a. are nursing or
b. are pregnant or
c. are not using an acceptable method of birth control, or do not plan to continue
using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
- history of or co-existing condition that, in the opinion of the investigator, would compromise the patientâ??s ability to comply with the trial or interfere with the evaluation of safety for the trial drug
- previous or concomitant malignancies at other sites, except effectively treated nonmelanoma
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.
- requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 that can not be stopped for the duration of trial participation
- known pre-existing interstitial lung disease
- presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohnâ??s disease, ulcerative colitis, malabsorption, or CTC grade greater than or equal to 2 diarrhoea of any aetiology) based on investigator assessment
- Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
- meningeal carcinomatosis
- symptomatic brain metastases (patients with as
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the safety, of afatinib 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-TKITimepoint: No specific timepoints as the primary outcome is to evaluate safety until time for sympotmatic progression
- Secondary Outcome Measures
Name Time Method Time to Symptomatic Progression in patients with locally advanced or Metastatic NSCLC harboring EGFR mutation(s)Timepoint: time from first administration of afatinib <br/ ><br>to the date of first documented clinically significant symptomatic progression that required <br/ ><br>change in or stopping anti-cancer treatment according to investigatorâ??s assessment.