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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01342965
First received: April 26, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, randomized, parallel arm study will assess the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer 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 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m2 iv on Day 1. Anticipated 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: erlotinib [Tarceva]
Drug: gemcitabine
Drug: cisplatin
 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ]

Estimated Enrollment: 210
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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: 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
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342965

Contacts
Contact: Please reference Study ID Number: YO25121 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
China
Not yet recruiting
Beijing, China, 101149
Active, not recruiting
Beijing, China, 100071
Not yet recruiting
Changchun, China, 130012
Active, not recruiting
Chongqing, China, 400038
Active, not recruiting
Chongqing, China, 400042
Not yet recruiting
Fuzhou, China, 350014
Not yet recruiting
Guangzhou, China, 510080
Not yet recruiting
Hangzhou, China, 310016
Not yet recruiting
Nanjing, China, 210002
Not yet recruiting
Shanghai, China, 200433
Not yet recruiting
Shanghai, China, 200030
Active, not recruiting
Shanghai, China, 200032
Active, not recruiting
Shantou, China, 515041
Active, not recruiting
Wuhan, China, 430023
Not yet recruiting
Xi An City, China, 710061
Malaysia
Completed
Kelantan, Malaysia, 16150
Active, not recruiting
Kuala Lumpur, Malaysia, 59100
Active, not recruiting
Nilai, Malaysia, 71800
Active, not recruiting
Pahang, Malaysia, 25100
Recruiting
Petaling Jaya, Malaysia, 46150
Recruiting
Petaling Jaya, Selangor, Malaysia, 46050
Active, not recruiting
Pulau Pinang, Malaysia, 11600
Philippines
Active, not recruiting
Davao, Philippines, 8000
Active, not recruiting
Desmarinas City, Philippines, 4114
Active, not recruiting
Manila, Philippines, 1000
Active, not recruiting
Quezon City, Philippines, 1104
Active, not recruiting
San Juan, Philippines, 1500
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01342965     History of Changes
Other Study ID Numbers: YO25121
Study First Received: April 26, 2011
Last Updated: May 7, 2013
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013