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
Condition: Lung Neoplasms
MeSH terms: Adenocarcinoma; Lung Neoplasms; Adenocarcinoma of Lung
Intervention: Afatinib; gefitinib
Intervention description: afatinib once daily; Gefitinib once daily
Intervention MeSH terms: Gefitinib; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

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 advanced adenocarcinoma of the lung.
    

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