Status:
COMPLETED
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients
Lead Sponsor:
University College, London
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992) to treat non-small cell lung cancer patients considered unfit for chemotherapy and have either suspected o...
Detailed Description
Lung cancer is most common cause of death from cancer, of which non-small cell lung cancer (NSCLC) accounts for \~80% of all cases with most patients presenting with advanced disease. Patients medical...
Eligibility Criteria
Inclusion
- Any stage not suitable for radical treatment
- Either:
- Confirmed activating EGFR mutation (exons 18-21; e.g. L858R, exon 19 deletions, exon 20 insertions, T790M, list is not exhaustive), and WHO PS 0-3 Or No tissue suitable for EGFR genotyping, failed genotype, or EGFR genotyping unavailable, and NSCLC Adenocarcinoma sub-type, and
- Eligible smoking history:
- Never smoker (\<100 cigarettes in lifetime), or Former smoker (stopped \>1year ago and ≤10 pack-years) and WHO PS 0-2
- Unsuitable for or patient declining chemotherapy due to significant co-morbidity
- Measurable disease according to RECIST version 1.1
- Adequate haematopoietic, hepatic and renal function defined as follows:
- Absolute neutrophil count (ANC) ≤1.5 x 109/L and platelet count ≤100 x 109/L
- Bilirubin ≤1.5 x ULN, ALT (SGPT) ≤3 x ULN (or ≤ 5 x ULN in cases of liver metastases)
- Serum creatinine clearance ≥45 ml/min
- Palliative radiotherapy allowed unless to a solitary target lesion
- Age 18 or over (no upper age limit)
- Written informed consent that is consistent with ICH-GCP guidelines
Exclusion
- Previous treatment with afatinib (BIBW 2992), or any EGFR-directed inhibitor
- Any concurrent anticancer systemic therapy
- Prior chemotherapy for relapsed and/or metastatic NSCLC
- Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and registration
- Suitable for radical radiotherapy
- Palliative radiotherapy within 2 weeks prior to registration
- Palliative radiotherapy to a solitary target lesion
- Surgery (other than biopsy) within 4 weeks prior to registration
- Inability to take oral medication, requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption, any medical co- morbidity affecting gastrointestinal absorption
- Patients with current or pre-existing interstitial lung disease
- Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's participation in the trial
- Significant or recent acute gastrointestinal abnormalities with diarrhoea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE version 4.0 Grade ≥3 diarrhoea of any etiology at baseline
- Active brain metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants and/or leptomeningeal disease). Steroids will be allowed if administered as a stable (same) dose for at least one month before trial entry.
- Any other current malignancy or malignancy diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer)
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3 or more, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to registration
- Symptomatic left ventricular failure with NYHA classification of 3 or more
- Active viral hepatitis and/or known HIV positive
- Known or suspected active drug or alcohol abuse
- Use of any investigational drug within 8 weeks of registration.
- Known allergy to BIBW 2992 or other ingredients.
- Patients on steroids must have been on the same dose for at least 4 weeks.
- Inability to understand or to comply with the requirements of the trial, trial protocol or to provide informed consent.
- Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
- Women who are pregnant or breast feeding
- Requirement for treatment with any of the prohibited concomitant medications listed in protocol
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01415011
Start Date
December 1 2012
End Date
November 30 2018
Last Update
January 15 2019
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Bournemouth Hospital
Bournemouth, United Kingdom
2
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
3
James Paget University Hospital
Great Yarmouth, United Kingdom
4
East Kent Hospitals
Kent, United Kingdom