Overview

This trial is active, not recruiting.

Condition lung neoplasms
Treatments afatinib, gefitinib
Phase phase 2
Targets EGFR, HER2, HER4
Sponsor Boehringer Ingelheim
Start date December 2011
End date April 2016
Trial size 319 participants
Trial identifier NCT01466660, 1200.123, 2011-001814-33

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
afatinib once daily.
afatinib
afatinib once daily
(Active Comparator)
gefitinib once daily
gefitinib
Gefitinib once daily

Primary Outcomes

Measure
Progression-free survival (PFS)
time frame: 24 months
Time to Treatment Failure (TTF)
time frame: 24 months
Overall survival (OS)
time frame: 24 months
Progression free survival (PFS) at 12 months (if required)
time frame: 12 months
Incidence of treatment discontinuation at 12 months (if required)
time frame: 12 months
Disease control rate at 12 months (if required)
time frame: 12 months

Secondary Outcomes

Measure
Objective response rate (ORR)
time frame: 24 months
Time to objective response
time frame: 24 months
Duration of objective response
time frame: 24 months
Duration of disease control
time frame: 24 months
Tumour shirinkage
time frame: 24 months
Health-related quality of life (HRQoL)
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.