Overview

This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatment erlotinib [tarceva]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date April 2011
End date July 2017
Trial size 208 participants
Trial identifier NCT01310036, ML25637

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
erlotinib [tarceva]
150 mg orally daily

Primary Outcomes

Measure
Progression-free survival by RECIST (PFS1), defined as time from first dose until documented RECIST disease progression or death of any cause at any time, whichever occurs first
time frame: 42 months

Secondary Outcomes

Measure
Progression-free survival by investigator's discretion (PFS2), defined as time from first study dose to off-Tarceva PD assessed by investigator based on overall clinical evaluation not limited to RECIST
time frame: 42 months
Objective response rate (all patients and patients with EGFR mutation E19del or L858R)
time frame: 42 months
Disease control rate (all patients and patients with EGFR mutation E19del or L858R)
time frame: 42 months
Progression-free survival (patients with EGFR mutation E19del or L858R)
time frame: 42 months
Overall survival (all patients and patients with EGFR mutation E19del or L858R)
time frame: 42 months
Safety: Incidence of adverse events
time frame: 42 months
Correlation between EGFR mutations in plasma and clinical outcome (ORR/PFS/OS)
time frame: 42 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 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)

Additional Information

Official title An Open-label Multi-center Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond Disease Progression in NSCLC Patients Who Harbour EGFR Mutations
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.