An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations
Overview
- Phase
- Phase 2
- Intervention
- Erlotinib
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 208
- Locations
- 22
- Primary Endpoint
- Progression-free Survival Per RECIST, v. 1.1 (PFS1)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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)
Arms & Interventions
Erlotinib
Erlotinib 150 mg daily
Intervention: Erlotinib
Outcomes
Primary Outcomes
Progression-free Survival Per RECIST, v. 1.1 (PFS1)
Time Frame: 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 Outcomes
- Progression-free Survival Per Investigator (PFS2)(Approximately 68 months)
- Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R(Approximately 68 months)
- Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R(Approximately 68 months)
- Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)(Approximately 68 months)
- Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R(Approximately 68 months)
- Number of Participants With Adverse Events(Approximately 68 months)
- Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)(Approximately 68 months)