TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)
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|ClinicalTrials.gov Identifier: NCT02920476|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2016
Results First Posted : December 17, 2019
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Lung Carcinoma||Drug: TAS-102||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung|
|Actual Study Start Date :||July 19, 2017|
|Actual Primary Completion Date :||December 3, 2018|
|Estimated Study Completion Date :||July 30, 2021|
Experimental: Treatment arm
Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.
Days 6 through 7: Rest
Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
Days 13 through 28: Rest
Other Name: Lonsurf
- Objective Response Rate (ORR) [ Time Frame: 1 year ]To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.
- Clinical Benefit Rate [ Time Frame: 1 year ]To determine the percentage of subjects who derive clinical benefit by RECIST 1.1 criteria. The clinical benefit rate is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.
- Overall Survival (OS) [ Time Frame: 1 year ]To determine the overall survival in months
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): NCT02920476
|United States, Florida|
|UF Health Cancer Center|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Dennie Jones, MD||University of Florida|