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 | Completed Phase 2 Results

• 1 other identifier: ML25637
• Study Type: interventional
• Target: 208
• Locations: 4 countries
• Sites: 22

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Per RECIST, v. 1.1 (PFS1)

  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.

  Approximately 68 months

Secondary Outcomes (7)

• 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

Study Arms (1)

Erlotinib

EXPERIMENTAL

Erlotinib 150 mg daily

Drug: Erlotinib

Interventions

Erlotinib DRUG

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

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (22)

Princess Margaret Hospital; Oncology

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, Hong Kong

Location

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, Hong Kong

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Gil Hospital. Gachon University

Incheon, 405-760, South Korea

Location

Asan Medical Center; Medical Oncology

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Yonsei University Severance Hospital; Medical Oncology

Seoul, 120-752, South Korea

Location

Changhua Christian Hospital; Internal Medicine

Changhua, 500, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

Kaohsiung City, 00833, Taiwan

Location

Veterans General Hospital; Internal Medicine

Kaohsiung City, 813, Taiwan

Location

China Medical University Hospital; Pulmonary and Critical Care Medicine

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital; Dept of Internal Medicine

Taichung, 407, Taiwan

Location

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

Tainan, 704, Taiwan

Location

Chi-Mei Medical Centre; Hematology & Oncology

Tainan, 710, Taiwan

Location

National Taiwan Uni Hospital; Internal Medicine

Taipei, 100, Taiwan

Location

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

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation - Linkou; Chest Dept

Taoyuan District, 333, Taiwan

Location

Chulalongkorn Hospital; Medical Oncology

Bangkok, 10330, Thailand

Location

Pramongkutklao Hospital; Medicine - Medical Oncology Unit

Bangkok, 10400, Thailand

Location

Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

Songkhla, 90110, Thailand

Location

Related Publications (1)

• 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.

  PMID: 26720423 DERIVED

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: March 7, 2011
• Study Start: April 30, 2011
• Primary Completion: February 14, 2014
• Study Completion: December 30, 2016
• Last Updated: September 12, 2018
• Results First Posted: September 12, 2018

Record last verified: 2018-09

Locations

TW (10); HK (3); KR (6); TH (3)