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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

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups

Outcome Description:

The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.

Outcome Time Frame:

Baseline to Day 56

Safety Issue:


Principal Investigator

Andrea Pirzkall, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

March 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tarceva
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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