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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms

Treatments: Drug: gefitinib; Drug: Afatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01466660

2011-001814-33 (EudraCT Number)

1200.123

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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319 participants in 2 patient groups

afatinib

Experimental group

Description:

afatinib once daily.

Treatment:

Drug: Afatinib

gefitinib

Active Comparator group

Description:

gefitinib once daily

Treatment:

Drug: gefitinib