A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy

An Parallel Phase II Study of Tarceva (Erlotinib) in Patients With Advanced Non-small Cell Lung Cancer (Stage IIIB/IV) Not Pre-treated by Chemotherapy Including Dose Escalation to Toxicity in Current and Former Smokers

This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13274
  • Villejuif, France, 94805
• Germany
  • Hamburg, Germany, 22045
• Italy
  • Milano, Italy, 20162
  • Rozzano, Italy, 20089
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
  • Maastricht, Netherlands, 6229 HX
• Spain
  • Barcelona, Spain, 08035
  • Barcelona, Spain, 08907
  • Madrid, Spain, 28041
• United Kingdom
  • Manchester, United Kingdom, M2O 4BX

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;
• histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• no previous chemotherapy.

Exclusion Criteria:

• previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
• clinical evidence of brain metastasis;
• any unstable systemic disease;
• unable to take oral medication;
• any significant ophthalmological abnormality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Never Smokers; Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.	Drug: erlotinib [Tarceva]; Erlotinib tablets taken orally once daily in the morning.; Other Names: Tarceva
Experimental: Current/Former Smokers; Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.	Drug: erlotinib [Tarceva]; Erlotinib tablets taken orally once daily in the morning.; Other Names: Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Progression Rate (NPR) at 8 Weeks	Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Objective response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). The patient's best response assignment depended on the achievement of both measurement and confirmation criteria. To be assigned the status of PR or CR, changes in tumour measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.	Up to 2 years
Disease Control Rate	Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.	Up to 2 years
Duration of Response	Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) until the first date Progressive Disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until the date of death. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	Up to 2 years
Time to Progression	Time to progression was defined as the time from start of treatment until the first date criteria for Progressive Disease (PD) was met (taking as reference the smallest measurements recorded since the treatment started). Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	Up to 2 years
Progression-Free Survival	Progression-Free Survival (PFS) was defined as the time in months from the start of treatment until the first date criteria for Progressive Disease (PD) were met (taking as reference the smallest measurements recorded since the treatment started), or the date of death for any reason in the absence of PD. Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.	Up to 2 years
Overall Survival	Overall survival was defined as the time in months from the start of treatment to the date of death irrespective of the cause of death.	Up to 2 years
Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.	Up to 2 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

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: MO18660