A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

NCT ID: NCT01310036

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-12-30

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib

Erlotinib 150 mg daily

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.

Interventions

Erlotinib

Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Tarceva

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Princess Margaret Hospital; Oncology

Hong Kong, , Hong Kong

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, , Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, , Hong Kong

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Gil Hospital. Gachon University

Incheon, , South Korea

Asan Medical Center; Medical Oncology

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul St Mary's Hospital

Seoul, , South Korea

Yonsei University Severance Hospital; Medical Oncology

Seoul, , South Korea

Changhua Christian Hospital; Internal Medicine

Changhua, , Taiwan

Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

Kaohsiung City, , Taiwan

Veterans General Hospital; Internal Medicine

Kaohsiung City, , Taiwan

China Medical University Hospital; Pulmonary and Critical Care Medicine

Taichung, , Taiwan

Taichung Veterans General Hospital; Dept of Internal Medicine

Taichung, , Taiwan

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

Tainan City, , Taiwan

Chi-Mei Medical Centre; Hematology & Oncology

Tainan City, , Taiwan

National Taiwan Uni Hospital; Internal Medicine

Taipei, , Taiwan

Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

Taipei, , Taiwan

Chang Gung Medical Foundation - Linkou; Chest Dept

Taoyuan District, , Taiwan

Chulalongkorn Hospital; Medical Oncology

Bangkok, , Thailand

Pramongkutklao Hospital; Medicine - Medical Oncology Unit

Bangkok, , Thailand

Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

Songkhla, , Thailand

Countries

Hong Kong; South Korea; Taiwan; Thailand

References

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.

Reference Type: DERIVED

PMID: 26720423 (View on PubMed)

Other Identifiers

ML25637

Identifier Type: -

Identifier Source: org_study_id