Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Tarceva (Erlotinib) Versus Gemcitabine/Cisplatin as First-Line Treatment in Patients With Non-Small Cell Lung Cancer With EGFR Mutations

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 26, 2011
Last updated: November 10, 2014
Last verified: November 2014

This open-label, randomized, parallel arm study will assess the efficacy and saf ety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung canc er with EGFR mutations in their tumours. Patients will be randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m2 in travenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m2 iv on Day 1. Anticipate d time on study treatment is until disease progression or unacceptable toxicity occurs (or up to 4 cycles of combined chemotherapy).

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: cisplatin
Drug: erlotinib [Tarceva]
Drug: gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multiple Center, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV NSCLC Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumor

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (complete response + partial response) [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Disease control rate (complete response + partial response + stable disease) [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) questionnaire [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: March 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150 mg orally daily, until disease progression or unacceptable toxicity
Active Comparator: 2 Drug: cisplatin
75 mg/m2 intravenously on Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity, or up to 4 cycles, whichever comes first
Drug: gemcitabine
1250 mg/m2 intravenously on Days 1 and 8 of each 3-week cycle, until disease progression or unacceptable toxicity, or up to 4 cycles, whichever comes first


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer
  • Presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumours
  • Measurable disease according to RECIST criteria
  • European Cooperative Oncology Group (ECOG) performance status </= 2

Exclusion Criteria:

  • Prior exposure to agents directed at the human epidermal receptor (HER) axis (e.g. but not limited to erlotinib, gefitinib, cetuximab, trastuzumab)
  • Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease
  • Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease
  • Any inflammatory changes of the surface of the eye
  • >/= grade 2 peripheral neuropathy
  • History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months
  • HIV infection
  • Pregnant, nursing or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01342965

Beijing, China, 101149
Beijing, China, 100071
Changchun, China, 130012
ChongQing, China, 400042
Chongqing, China, 400038
Fuzhou, China, 350014
Guangzhou, China
Hangzhou, China
Nanjing, China
Shanghai, China, 200030
Shanghai, China, 200032
Shanghai, China, 200433
Shantou, China, 515041
Wuhan, China, 430023
Xi'an, China, 710061
Kota Bharu Kelantan, Malaysia, 16150
Kuala Lumpur, Malaysia, 59100
Kuala Lumpur, Malaysia, 50603
Nilai, Malaysia, 71800
Pahang, Malaysia, 25100
Petaling Jaya, Malaysia, 46150
Petaling Jaya, Selangor, Malaysia, 46050
Pulau Pinang, Malaysia, 11600
Davao, Philippines, 8000
Desmarinas City, Philippines, 4114
Manila, Philippines, 1000
Quezon City, Philippines, 1104
San Juan, Philippines, 1500
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01342965     History of Changes
Other Study ID Numbers: YO25121
Study First Received: April 26, 2011
Last Updated: November 10, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 20, 2014