Clinical trial NCT01310036: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Progression-free Survival Per RECIST, v. 1.1 (PFS1)
timeFrame: Approximately 68 months
Secondary outcomes:
measure: Progression-free Survival Per Investigator (PFS2)
timeFrame: Approximately 68 months
measure: Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R
timeFrame: Approximately 68 months
measure: Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R
timeFrame: Approximately 68 months
measure: Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)
timeFrame: Approximately 68 months
measure: Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R
timeFrame: Approximately 68 months
measure: Number of Participants With Adverse Events
timeFrame: Approximately 68 months
measure: Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)
timeFrame: Approximately 68 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital; Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital; Clinical Oncology
city: Shatin
country: Hong Kong
facility: Prince of Wales Hosp; Dept. Of Clinical Onc
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Gil Hospital. Gachon University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital; Medical Oncology
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Internal Medicine
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
city: Kaohsiung
country: Taiwan
facility: Veterans General Hospital; Internal Medicine
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Pulmonary and Critical Care Medicine
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Dept of Internal Medicine
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Centre; Hematology & Oncology
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Internal Medicine
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Chest Dept
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Medical Oncology
city: Bangkok
country: Thailand
facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.