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

Launched by BOEHRINGER INGELHEIM · Nov 4, 2011

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Eligibility criteria

• Inclusion criteria:
• • 1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
• • 2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
• • 3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• • 5. Age \>= 18 years.
• 6. 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:
• • 1. 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.
• • 2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
• • 3. Major surgery within 4 weeks of study randomisation.
• • 4. Active brain metastases
• • 5. Meningeal carcinomatosis.
• • 6. 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.
• • 7. Known pre-existing interstitial lung disease.
• • 8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
• • 9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
• • 10. 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.
• • 11. Pregnancy or breast-feeding.
• • 12. Active hepatitis and/or known HIV carrier
• • 13. Any prohibited concomitant medications for therapy with afatinib or gefitinib