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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

NCT01310036

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Interventions: Erlotinib

Countries: Hong Kong, South Korea, Taiwan, Thailand

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (22)

Hong Kong, Hong Kong
Hong Kong, Hong Kong
Shatin, Hong Kong
Gyeonggi-do, South Korea
Incheon, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Changhua, Taiwan
Kaohsiung City, Taiwan
Kaohsiung City, Taiwan
Taichung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Bangkok, Thailand
Bangkok, Thailand
Songkhla, Thailand