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COMPLETEDPHASE2

A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

A Randomized, Open-Label, Multi-Center, International Phase 2 Study of TAS-114 in Combination With S-1 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

NCT02855125•Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC. The study will be conducted internationally in 2 regions: Asian \[Japan\] and Western \[Europe and US\]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.

Detailed Description

Randomization will take place once the consented patient has completed all the necessary baseline procedures and is deemed eligible for study entry. Treatment assignment will be done centrally using a dynamic allocation method (biased coin) via an interactive voice/web response system (IXRS) stratified by: * Geographical region (Region 1: Asian \[Japan\]; Region 2: Western \[Europe and US\]) * Histological subtypes (nonsquamous cell carcinoma \[including mixed\] and squamous cell carcinoma)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years old (≥ 20 years old in Japan);
•2. Histologically diagnosed or cytologically proven advanced or metastatic NSCLC patients, either Stage IIIB/Stage IV disease (according to Version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or recurrent disease following radiation therapy or surgical resection;
•3. Patients who had received at least 2 prior therapies for advanced or metastatic disease condition, including platinum doublet and pemetrexed, docetaxel, or immunotherapy, and were refractory to or unable to tolerate their last prior therapy
•4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009);
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
•6. Predicted life expectancy of at least 3 months;
•7. Able to take medications orally;
•8. Adequate organ function
•9. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
•10. Willing and able to comply with required scheduled visits and study procedures.

Exclusion Criteria

•1. Treatment with any of the following within the specified time frame prior to the study drug administration:
•* Major surgery within prior 4 weeks and minor surgery within 7 days;
•* Radiotherapy for extended field within prior 4 weeks or limited field within prior 2 weeks;
•* Any anticancer therapy or investigational agent within prior 3 weeks.
•2. A serious illness or medical condition
•3. Concomitant treatment with the following drugs that may interact with S-1:
•Sorivudine, brivudine, uracil, eniluracil, folinate/folinic acid, Cimetidine, dipyridamole, and nitroimidazoles, including metronidazole and misonidazoleMethotrexate, Clozapine,Allopurinol,Phenytoin,Flucytosine, a fluorinated pyrimidine antifungal agent,Coumarin-derivative anticoagulant
•4. Known hypersensitivity to S-1 or its metabolites (eg, 5-FU);
•5. Previous use of TAS-114, S-1, and 5-FU drugs;
•6. A pregnant or lactating female or possibly pregnant women, or men or women wishing to have children during the study period;
+1 more criteria

Locations (30)

Loma Linda, California, United States

Gainesville, Florida, United States

Cleveland, Ohio, United States

Portland, Oregon, United States

Dallas, Texas, United States

Seattle, Washington, United States

Caen, France

Lille, France

Marseille, France

Paris, France

Key Dates

Start Date

August 29, 2016

Primary Completion Date

September 30, 2017

Completion Date

November 30, 2017

Last Updated

September 19, 2024

Enrollment

128

ACTUAL participants

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

TAS-114

DRUG

S-1

DRUG

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Locally Advanced or Metastatic Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

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Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer