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

Roche

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib; Drug: Pertuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02507375

WO20024

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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).

Treatment:

Drug: Pertuzumab

Drug: Erlotinib

Cohort 2

Experimental group

Description:

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).

Treatment:

Drug: Pertuzumab

Drug: Erlotinib