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Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

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ClinicalTrials.gov Identifier: NCT02000531
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Erlotinib Drug: Chemotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib-Chemotherapy
Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
Drug: Erlotinib
150 mg oral dose of erlotinib given once daily
Other Name: Tarceva

Drug: Chemotherapy
Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
Other Name: Gemcitabine/Cisplatin

Active Comparator: Chemotherapy-Erlotinib
Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Drug: Erlotinib
150 mg oral dose of erlotinib given once daily
Other Name: Tarceva

Drug: Chemotherapy
Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
Other Name: Gemcitabine/Cisplatin




Primary Outcome Measures :
  1. Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events [ Time Frame: within 3 years, 9 months (data cut-off December 2014) ]
    Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.


Secondary Outcome Measures :
  1. Participants With Adverse Events [ Time Frame: start of second-line treatment to data cut-off in December 2014 (within 12 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant in ENSURE trial
  • Disease progression during first-line treatment

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000531


Locations
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China
Beijing, China, 101149
Changchun, China, 130012
Chongqing, China, 400038
ChongQing, China, 400042
Fuzhou, China, 350014
Guangzhou, China
Nanjing, China
Shanghai, China, 200030
Shanghai, China, 200433
Shantou, China, 515041
Wuhan, China, 430023
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02000531     History of Changes
Other Study ID Numbers: ML29028
First Posted: December 4, 2013    Key Record Dates
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016
Last Verified: December 2015

Keywords provided by Hoffmann-La Roche:
Non-small-cell lung cancer (NSCLC)

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