A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT02507375

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-12-31

Brief Summary

This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO).

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib will be administered as oral tablets.

Pertuzumab

Intervention Type: DRUG

Pertuzumab will be administered as intravenous (IV) infusion.

Cohort 2

Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 150 mg orally (PO).

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib will be administered as oral tablets.

Pertuzumab

Intervention Type: DRUG

Pertuzumab will be administered as intravenous (IV) infusion.

Interventions

Erlotinib

Erlotinib will be administered as oral tablets.

Intervention Type: DRUG

Pertuzumab

Pertuzumab will be administered as intravenous (IV) infusion.

Intervention Type: DRUG

Other Intervention Names

Tarceva; Perjeta

Eligibility Criteria

Inclusion Criteria

• Adult patients greater than or equal to 18 years of age
• Histological confirmation of non-small cell lung cancer (NSCLC)
• Locally advanced or metastatic disease
• Failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
• Life expectancy of more than or equal to 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Baseline Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 50%
• A negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
• Availability of histological Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue

Exclusion Criteria

• Prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study Day -8
• Prior treatment with any agent which targets growth factors or their receptors
• Patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
• History of clinically significant cardiovascular disease
• History or evidence of central nervous system metastases
• Treatment with any investigational drug within 28 days of the start of the study (day -8)
• Prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Antwerp, , Belgium

Barcelona, , Spain

Manchester, , United Kingdom

Countries

Belgium; Spain; United Kingdom

Other Identifiers

WO20024

Identifier Type: -

Identifier Source: org_study_id

NCT02514096

Identifier Type: -

Identifier Source: nct_alias