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
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: November 4, 2011
Last updated: March 5, 2014
Last verified: March 2014
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 advanced adenocarcinoma of the lung.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung
Primary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to Treatment Failure (TTF) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to objective response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Duration of objective response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Duration of disease control [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Tumour shirinkage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Health-related quality of life (HRQoL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
afatinib once daily.
afatinib once daily
Active Comparator: gefitinib
gefitinib once daily
Gefitinib once daily
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466660
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 4, 2011
||March 5, 2014
||Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Hong Kong: Department of Health
Ireland: Irish Medicines Board
Norway: Norwegian Medicines Agency
Singapore: Health Sciences Authority
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action