A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations

Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor

This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Study Overview

• Status: Completed
• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: erlotinib [Tarceva]

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4004
  • Sofia, Bulgaria, 1756
  • Sofia, Bulgaria, 1431
  • Sofia, Bulgaria, 1527
  • Sofia, Bulgaria, 1404
  • Stara Zagora, Bulgaria, 8000
  • Varna, Bulgaria, 9002
  • Varna, Bulgaria, 9010
  • Veliko Tarnovo, Bulgaria, 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
• At least one measurable lesion according to RECIST criteria
• European Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate hematological, liver and renal function
• Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible

Exclusion Criteria:

• Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study)
• History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
• Symptomatic cerebral metastases
• Any significant ophthalmologic abnormality
• Use of coumarins
• Pregnant or breast-feeding women
• Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: erlotinib [Tarceva]; 150 mg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (Tumour Assessments According to RECIST Criteria)	Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.	Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (Investigator Assessed)	Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.	Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)
Safety: Incidence of Adverse Events	An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.	Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.
Overall Survival	The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.	Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 13, 2011

Study Record Updates

• Last Update Posted (Estimate): February 2, 2016
• Last Update Submitted That Met QC Criteria: January 3, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: ML25423