Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc (NSCLC EGFR TKI)
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ClinicalTrials.gov Identifier: NCT01955421 |
Recruitment Status : Unknown
Verified July 2015 by Li Zhang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : October 7, 2013
Last Update Posted : July 3, 2015
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Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
Tracking Information | |||
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First Submitted Date ICMJE | September 24, 2013 | ||
First Posted Date ICMJE | October 7, 2013 | ||
Last Update Posted Date | July 3, 2015 | ||
Study Start Date ICMJE | July 2013 | ||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
disease control rate [ Time Frame: 2 years ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc | ||
Official Title ICMJE | A Randomized, Open-label Phase II Trial of Erlotinib 100mg Daily Versus Gefitinib 250mg Daily in Patients With Advanced Non-small Cell Lung Cancer Who Harbor EGFR Mutations. | ||
Brief Summary | This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224 eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib 250mg daily in a 1:1 ratio until patients experience disease progression. Independent assessment of the major endpoints will be completed in a treatment-blinded manner. Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs. second-line therapy). Tumor response and progression will be assessed according to RECIST 1.1. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Stage Non Small Cell Lung Cancer | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Zhao S, Zhang Z, Fang W, Zhang Y, Zhang Z, Hong S, Ma Y, Zhou T, Yang Y, Huang Y, Zhao H, Zhang L. Efficacy and Tolerability of Erlotinib 100 mg/d vs. Gefitinib 250 mg/d in EGFR-Mutated Advanced Non-small Cell Lung Cancer (E100VG250): An Open-Label, Randomized, Phase 2 Study. Front Oncol. 2020 Nov 10;10:587849. doi: 10.3389/fonc.2020.587849. eCollection 2020. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
224 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Study Completion Date ICMJE | Not Provided | ||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | China | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01955421 | ||
Other Study ID Numbers ICMJE | E100VG250 Tarceva100vsIressa250 ( Registry Identifier: Tarceva100vsIressa250 ) |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Li Zhang, Sun Yat-sen University | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Sun Yat-sen University | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Sun Yat-sen University | ||
Verification Date | July 2015 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |