A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: July 6, 2009
Last updated: March 3, 2014
Last verified: March 2014

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Drug: gemcitabine
Phase 2

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 Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: tumour assessment after every 2nd 4-week cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate,disease control rate,duration of response,overall survival [ Time Frame: tumour assessment after every 2nd 4-week cycle, follow-up for survival at least 12 months ] [ Designated as safety issue: No ]
  • SAEs, AEs, laboratory parameters, vital signs, further/second line treatment. [ Time Frame: Throughout study, laboratory parameters assessed days 1,8,15 and 22 of cycles 1+2, days 1,8 and 15 of cycles 3-6 and every 4 weeks thereafter ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po on days 15-28 of each 4 week cycle
Drug: gemcitabine
1250mg/m2/day on days 1 and 8 of each 4 week cycle
Active Comparator: 2 Drug: gemcitabine
1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle


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

Inclusion Criteria:

  • adult patients, >=70 years of age or with ECOG PS of 2;
  • advanced (stage IIIB or IV)non-small cell lung cancer;
  • no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion Criteria:

  • active brain metastasis or spinal cord suppression;
  • unstable systemic disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00940875

Australia, New South Wales
Port Macquarie, New South Wales, Australia, 2444
Randwick, New South Wales, Australia, 2031
Sydney, New South Wales, Australia, 2139
Sydney, New South Wales, Australia, 2747
Tweed Heads, New South Wales, Australia, NSW 2485
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Greenslopes, Queensland, Australia, 4120
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Richmond, South Australia, Australia, 3121
Terrace Gardens, South Australia, Australia, 5065
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Bendigo, Victoria, Australia, 3550
Heidelberg, Victoria, Australia, 3084
Melbourne, Victoria, Australia, 3002
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940875     History of Changes
Other Study ID Numbers: ML22429
Study First Received: July 6, 2009
Last Updated: March 3, 2014
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
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
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 31, 2015