Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population
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
1 other identifier
interventional
45
1 country
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2014
Shorter than P25 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 13, 2016
CompletedJanuary 13, 2016
December 1, 2015
11 months
November 27, 2013
December 9, 2015
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
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.
within 3 years, 9 months (data cut-off December 2014)
Secondary Outcomes (1)
Participants With Adverse Events
start of second-line treatment to data cut-off in December 2014 (within 12 months)
Study Arms (2)
Erlotinib-Chemotherapy
EXPERIMENTALErlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
Chemotherapy-Erlotinib
ACTIVE COMPARATORChemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Interventions
150 mg oral dose of erlotinib given once daily
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)
Eligibility Criteria
You may qualify if:
- Participant in ENSURE trial
- Disease progression during first-line treatment
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Beijing, 101149, China
Unknown Facility
Changchun, 130012, China
Unknown Facility
Chongqing, 400038, China
Unknown Facility
Chongqing, 400042, China
Unknown Facility
Fuzhou, 350014, China
Unknown Facility
Guangzhou, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, 200030, China
Unknown Facility
Shanghai, 200433, China
Unknown Facility
Shantou, 515041, China
Unknown Facility
Wuhan, 430023, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- HoffmannLa Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 4, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 13, 2016
Results First Posted
January 13, 2016
Record last verified: 2015-12