Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992) to treat non-small cell lung cancer patients considered unfit for chemotherapy and have either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: Boehringer Ingelheim
• Treatments: Afatinib

Criteria

Inclusion Criteria:

• Any stage not suitable for radical treatment

• Either:

Confirmed activating EGFR mutation (exons 18-21; e.g. L858R, exon 19 deletions, exon 20 insertions, T790M, list is not exhaustive), and WHO PS 0-3 Or No tissue suitable for EGFR genotyping, failed genotype, or EGFR genotyping unavailable, and NSCLC Adenocarcinoma sub-type, and

Eligible smoking history:

Never smoker (<100 cigarettes in lifetime), or Former smoker (stopped >1year ago and ≤10 pack-years) and WHO PS 0-2

• Unsuitable for or patient declining chemotherapy due to significant co-morbidity

• Measurable disease according to RECIST version 1.1

• Adequate haematopoietic, hepatic and renal function defined as follows:

Absolute neutrophil count (ANC) ≤1.5 x 109/L and platelet count ≤100 x 109/L

• Bilirubin ≤1.5 x ULN, ALT (SGPT) ≤3 x ULN (or ≤ 5 x ULN in cases of liver metastases)

• Serum creatinine clearance ≥45 ml/min

• Palliative radiotherapy allowed unless to a solitary target lesion

• Age 18 or over (no upper age limit)

• Written informed consent that is consistent with ICH-GCP guidelines

Exclusion Criteria:

• Previous treatment with afatinib (BIBW 2992), or any EGFR-directed inhibitor

• Any concurrent anticancer systemic therapy

• Prior chemotherapy for relapsed and/or metastatic NSCLC

• Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and registration

• Suitable for radical radiotherapy

• Palliative radiotherapy within 2 weeks prior to registration

• Palliative radiotherapy to a solitary target lesion

• Surgery (other than biopsy) within 4 weeks prior to registration

• Inability to take oral medication, requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption, any medical co- morbidity affecting gastrointestinal absorption

• Patients with current or pre-existing interstitial lung disease

• Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's participation in the trial

• Significant or recent acute gastrointestinal abnormalities with diarrhoea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE version 4.0 Grade ≥3 diarrhoea of any etiology at baseline

• Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants and/or leptomeningeal disease). Steroids will be allowed if administered as a stable (same) dose for at least one month before trial entry.

• Any other current malignancy or malignancy diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer)

• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3 or more, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to registration

• Symptomatic left ventricular failure with NYHA classification of 3 or more

• Active viral hepatitis and/or known HIV positive

• Known or suspected active drug or alcohol abuse

• Use of any investigational drug within 8 weeks of registration.

• Known allergy to BIBW 2992 or other ingredients.

• Patients on steroids must have been on the same dose for at least 4 weeks.

• Inability to understand or to comply with the requirements of the trial, trial protocol or to provide informed consent.

• Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial

• Women who are pregnant or breast feeding

• Requirement for treatment with any of the prohibited concomitant medications listed in protocol