A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer

NCT00855894 | Completed Phase 2 Results

• 2 other identifiers: TOC4603gGO01357
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Tarceva; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline to Day 56

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  Baseline to the end of the study (up to 3 years)

• Overall Survival (OS)

  Baseline to the end of the study (up to 3 years)

• Percentage of Patients With an Objective Response (OR)

  Baseline to the end of the study (up to 3 years)

• Percentage of Patients With Disease Control (DC) at Day 56

  Baseline to Day 56

Study Arms (1)

Pertuzumab + erlotinib

EXPERIMENTAL

Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.

Drug: Pertuzumab; Drug: Erlotinib

Interventions

Pertuzumab DRUG

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).

Also known as: Perjeta

Pertuzumab + erlotinib

Erlotinib DRUG

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.

Also known as: Tarceva

Pertuzumab + erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead
• Roche Pharma AG: collaborator

Study Sites (10)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Rancho Mirage, California, 92270, United States

Location

Unknown Facility

Omaha, Nebraska, 68114, United States

Location

Unknown Facility

Seattle, Washington, 98195, United States

Location

Unknown Facility

Adelaide, 5000, Australia

Location

Unknown Facility

Chermside, 4032, Australia

Location

Unknown Facility

East Melbourne, 3002, Australia

Location

Unknown Facility

Heidelberg, 3084, Australia

Location

Unknown Facility

Herston, 4029, Australia

Location

Unknown Facility

Sydney, 2065, Australia

Location

Related Publications (1)

• Hughes B, Mileshkin L, Townley P, Gitlitz B, Eaton K, Mitchell P, Hicks R, Wood K, Amler L, Fine BM, Loecke D, Pirzkall A. Pertuzumab and erlotinib in patients with relapsed non-small cell lung cancer: a phase II study using 18F-fluorodeoxyglucose positron emission tomography/computed tomography imaging. Oncologist. 2014 Feb;19(2):175-6. doi: 10.1634/theoncologist.2013-0026. Epub 2014 Jan 23.

  PMID: 24457379 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pertuzumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800 821-8590

Study Officials

• Andrea Pirzkall, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 21, 2013
• Results First Posted: May 1, 2013

Record last verified: 2013-05

Locations

AU (6); US (4)