An open label, single-arm phase IV study to assess the efficacy and safety of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring an EGFR mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy

Boehringer Ingelheim RCV GmbH & Co KG0 sites282 target enrollmentFebruary 13, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic non-small cell lung cancer harbouring an EGFR mutation (Del 19 or L858R)
Sponsor: Boehringer Ingelheim RCV GmbH & Co KG
Enrollment: 282
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

February 13, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
•2\. Documented EGFR mutation (L858R and/or Deletion 19\) with no other known EGFR mutation.
•3\. Measureable disease according to RECIST 1\.1\.
•4\. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum\-based chemotherapy regimen.
•5\. Age \>18 years.
•6\. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1\.
•7\. Adequate organ function, defined as all of the following: Absolute neutrophil count (ANC) \> 1500 / mm3, Platelet count \>75,000 / mm3, Estimated creatinine clearance \> 45ml / min, Total Bilirubin \< 1\.5 times upper limit of institution normal, Aspartate amino transferase (AST) and alanine amino transferase (ALT) \< three times the upper limit of institution normal (ULN) (if related to liver metastases \< five times ULN).
•8\. Recovered from any previous therapy\-related toxicity to less than or equal to CTCAE Grade 1 at study entry (except for alopecia and stable sensory neuropathy which must be less than or equal to CTCAE Grade 2\).
•9\. Life expectancy of at least three months.
•10\. Written informed consent that is consistent with ICH\-GCP guidelines.

•1\. More than one line of prior therapy for disease.
•2\. Previously received less than 3 cycles of platinum\-based chemotherapy due to toxicity and/or intolerance of treatment.
•3\. Previous treatment with any EGFR targeting TKI or antibody.
•4\. Chemotherapy, biological therapy or investigational agents within three weeks prior to the start of study treatment.
•5\. Hormonal treatment within two weeks prior to start of study treatment.
•6\. Radiotherapy within 4 weeks prior to study treatment, except for palliative radiation to target organs other than chest and single dose palliative treatment for symptomatic metastasis.
•7\. Major surgery within 4 weeks before starting study treatment or surgery scheduled during the projected course of the study.
•8\. Known hypersensitivity to afatinib or the excipients of afatinib.
•9\. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator or myocardial infarction within 6 months prior to study treatment.
•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 28 days after treatment has ended.