Status:
COMPLETED
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive ad...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
- Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
- At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Age \>= 18 years.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =\< 3 x upper limit of normal (ULN), or AST and ALT =\<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =\<1.5 x ULN Absolute neutrophil count (ANC) \>=1.5 x 109/L Creatinine clearance \> 45ml / min Platelets \>= 75 x 109/L
- Exclusion criteria:
- Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
- Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
- Major surgery within 4 weeks of study randomisation.
- Active brain metastases
- Meningeal carcinomatosis.
- 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 in the opinion of investigator.
- Known pre-existing interstitial lung disease.
- Clinically relevant cardiovascular abnormalities as judged by the investigator.
- Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
- Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
- Pregnancy or breast-feeding.
- Active hepatitis and/or known HIV carrier
- Any prohibited concomitant medications for therapy with afatinib or gefitinib
Exclusion
Key Trial Info
Start Date :
December 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2019
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT01466660
Start Date
December 13 2011
End Date
April 12 2019
Last Update
April 7 2020
Active Locations (63)
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1
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia, 2050
2
St George Hospital
Kogarah, New South Wales, Australia, 2217
3
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
4
Haematology & Oncology Clinics of Australasia (HOCA)
South Brisbane, Queensland, Australia, 4101