A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pertuzumab; Erlotinib
Intervention description: After a single administration of a loading dose of 840 mg IV, patients received a maintenance dose of 420 mg IV every 3 weeks (q3w).; Patients received 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Intervention MeSH terms: Erlotinib Hydrochloride; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tarceva; NSCLC

Summary:

      This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with
      relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of
      the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response
      rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             imaging studies.

          -  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.

        Exclusion Criteria:

          -  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
             bone fractures).

          -  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
             angina.

          -  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%.

          -  Claustrophobia.

          -  Any other disease, condition, physical examination finding, or clinical laboratory
             finding that, in the opinion of the investigator, makes the patient inappropriate for
             the study.