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A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Primary Purpose

Non-Squamous Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Stage IV or recurrent non-small cell lung cancer (NSCLC)
  • Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
  • Measurable disease (at least one lesion >= 10 mm in longest diameter)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Patients with T790M single mutation only
  • Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
  • Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
  • Symptomatic or uncontrolled central nervous system (CNS) metastases
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
  • Any significant ophthalmologic abnormality
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)

Sites / Locations

  • Princess Margaret Hospital; Oncology
  • Queen Elizabeth Hospital; Clinical Oncology
  • Prince of Wales Hosp; Dept. Of Clinical Onc
  • Seoul National University Bundang Hospital
  • Gil Hospital. Gachon University
  • Asan Medical Center; Medical Oncology
  • Samsung Medical Center
  • Seoul St Mary's Hospital
  • Yonsei University Severance Hospital; Medical Oncology
  • Changhua Christian Hospital; Internal Medicine
  • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
  • Veterans General Hospital; Internal Medicine
  • China Medical University Hospital; Pulmonary and Critical Care Medicine
  • Taichung Veterans General Hospital; Dept of Internal Medicine
  • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
  • Chi-Mei Medical Centre; Hematology & Oncology
  • National Taiwan Uni Hospital; Internal Medicine
  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
  • Chang Gung Medical Foundation - Linkou; Chest Dept
  • Chulalongkorn Hospital; Medical Oncology
  • Pramongkutklao Hospital; Medicine - Medical Oncology Unit
  • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib

Arm Description

Erlotinib 150 mg daily

Outcomes

Primary Outcome Measures

Progression-free Survival Per RECIST, v. 1.1 (PFS1)
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

Secondary Outcome Measures

Progression-free Survival Per Investigator (PFS2)
PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.
Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R
ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R
DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R
OS was defined as the time from baseline to the date of death from any cause.
Number of Participants With Adverse Events
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)
This outcome measure was not assessed.

Full Information

First Posted
February 18, 2011
Last Updated
September 10, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01310036
Brief Title
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
Official Title
An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2011 (Actual)
Primary Completion Date
February 14, 2014 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib
Arm Type
Experimental
Arm Description
Erlotinib 150 mg daily
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression-free Survival Per RECIST, v. 1.1 (PFS1)
Description
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Time Frame
Approximately 68 months
Secondary Outcome Measure Information:
Title
Progression-free Survival Per Investigator (PFS2)
Description
PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.
Time Frame
Approximately 68 months
Title
Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R
Description
ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame
Approximately 68 months
Title
Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R
Description
DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Time Frame
Approximately 68 months
Title
Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)
Description
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Time Frame
Approximately 68 months
Title
Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R
Description
OS was defined as the time from baseline to the date of death from any cause.
Time Frame
Approximately 68 months
Title
Number of Participants With Adverse Events
Description
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Time Frame
Approximately 68 months
Title
Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)
Description
This outcome measure was not assessed.
Time Frame
Approximately 68 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult participants, >/= 18 years of age Stage IV or recurrent non-small cell lung cancer (NSCLC) Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only) Measurable disease (at least one lesion >= 10 mm in longest diameter) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hematological, renal and liver function Exclusion Criteria: Patients with T790M single mutation only Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease Symptomatic or uncontrolled central nervous system (CNS) metastases Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast Any significant ophthalmologic abnormality Pre-existing parenchymal lung disease such as pulmonary fibrosis Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Princess Margaret Hospital; Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gil Hospital. Gachon University
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Asan Medical Center; Medical Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital; Medical Oncology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Changhua Christian Hospital; Internal Medicine
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
Facility Name
Veterans General Hospital; Internal Medicine
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
China Medical University Hospital; Pulmonary and Critical Care Medicine
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital; Dept of Internal Medicine
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chi-Mei Medical Centre; Hematology & Oncology
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Chest Dept
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26720423
Citation
Park K, Yu CJ, Kim SW, Lin MC, Sriuranpong V, Tsai CM, Lee JS, Kang JH, Chan KC, Perez-Moreno P, Button P, Ahn MJ, Mok T. First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer: The ASPIRATION Study. JAMA Oncol. 2016 Mar;2(3):305-12. doi: 10.1001/jamaoncol.2015.4921.
Results Reference
derived

Learn more about this trial

A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

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