An Open-label Phase II Multicenter Study of the Safety and Activity (as Measured by FDG-PET Imaging Changes) of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer
- Histologically confirmed non-small cell lung cancer (NSCLC).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Recurrent or progressive disease after receiving at least 1, but no more than two,
chemotherapy regimens for advanced or metastatic NSCLC.
- Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy,
radiotherapy, or investigational treatment) to National Cancer Institute-Common
Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≤ 1 (excluding alopecia).
- Ability to comply with the study and follow-up procedures, including all specified
- Ability to take oral medication.
- Life expectancy ≥ 3 months.
- Measurable disease on computed tomography (CT).
- At least 1 extracerebral lesion on 2-deoxy-2-[18F]fluoro-D-glucose-positron emission
tomography (FDG-PET) scan that is suitable for response assessment, that is
measurable, and ≥ 15 mm on CT.
- Left ventricular ejection fraction (LVEF) ≥ 50%, as determined by echocardiogram or
MUltiple Gated Acquisition (MUGA) scan.
- For women of childbearing potential and men with partners of childbearing potential,
agreement to use a highly effective non-hormonal form of contraception or two
effective forms of non-hormonal contraception by the patient and/or partner.
- Availability and willingness to provide sufficient tumor tissue for testing for
epidermal growth factor receptor (EGFR) mutations, and other human epidermal growth
factor receptor (HER) pathway and NSCLC-related biomarkers.
- Prior treatment with an investigational or marketed agent for the purpose of
inhibiting HER family members (including HER1, HER2, HER3, and HER4). This includes,
but is not limited to erlotinib, gefitinib, pertuzumab, cetuximab, and panitumumab.
- Chemotherapy, radiotherapy, or investigational treatment within 28 days of start of
study (ie, prior to Day 0) or from which patients have not yet recovered.
- Inability to take oral medications, disease affecting gastrointestinal absorption, or
prior surgical procedure affecting gastrointestinal absorption.
- Uncontrolled diabetes.
- Clinical or radiographic evidence of new or progression of pre-existing central
nervous system (CNS) metastases.
- Current severe, uncontrolled systemic disease (eg, clinically significant
cardiovascular, pulmonary, or metabolic disease; wound-healing disorders; ulcers; or
- Current uncontrolled hypertension or unstable angina.
- History of congestive heart failure (CHF) of any New York Heart Association (NYHA)
criteria, or serious cardiac arrhythmia requiring treatment (exceptions: atrial
fibrillation, paroxysmal supraventricular tachycardia).
- History of myocardial infarction within 6 months of enrollment or history of unstable
- Any evidence of an unstable infection as suggested by an infectious process, coupled
with hypotension and/or tachycardia and/or fever and/or positive blood culture.
- Known human immunodeficiency virus (HIV) infection.
- Uncontrolled hypercalcemia.
- Pregnancy or lactation.
- History of another malignancy in the past 2 years, unless the malignancy has been
adequately treated, is currently not detectable, and is associated with a 5-year
survival > 90%.
- Any other disease, condition, physical examination finding, or clinical laboratory
finding that, in the opinion of the investigator, makes the patient inappropriate for