A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
- Registration Number
- NCT01310036
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erlotinib Erlotinib Erlotinib 150 mg daily
- Primary Outcome Measures
Name Time Method Progression-free Survival Per RECIST, v. 1.1 (PFS1) Approximately 68 months 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
Name Time Method Progression-free Survival Per Investigator (PFS2) Approximately 68 months 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 Approximately 68 months 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 Approximately 68 months 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) Approximately 68 months 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 Approximately 68 months OS was defined as the time from baseline to the date of death from any cause.
Number of Participants With Adverse Events Approximately 68 months 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) Approximately 68 months This outcome measure was not assessed.
Trial Locations
- Locations (22)
Changhua Christian Hospital; Internal Medicine
🇨🇳Changhua, Taiwan
Veterans General Hospital; Internal Medicine
🇨🇳Kaohsiung, Taiwan
Chang Gung Medical Foundation - Linkou; Chest Dept
🇨🇳Taoyuan, Taiwan
National Taiwan Uni Hospital; Internal Medicine
🇨🇳Taipei, Taiwan
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
🇹ðŸ‡Songkhla, Thailand
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
🇨🇳Tainan, Taiwan
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Taichung Veterans General Hospital; Dept of Internal Medicine
🇨🇳Taichung, Taiwan
Chi-Mei Medical Centre; Hematology & Oncology
🇨🇳Tainan, Taiwan
China Medical University Hospital; Pulmonary and Critical Care Medicine
🇨🇳Taichung, Taiwan
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
🇹ðŸ‡Bangkok, Thailand
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Severance Hospital; Medical Oncology
🇰🇷Seoul, Korea, Republic of
Gil Hospital. Gachon University
🇰🇷Incheon, Korea, Republic of
Asan Medical Center; Medical Oncology
🇰🇷Seoul, Korea, Republic of
Queen Elizabeth Hospital; Clinical Oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Princess Margaret Hospital; Oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
🇨🇳Taipei, Taiwan
Chulalongkorn Hospital; Medical Oncology
🇹ðŸ‡Bangkok, Thailand
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Prince of Wales Hosp; Dept. Of Clinical Onc
ðŸ‡ðŸ‡°Shatin, Hong Kong