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Advanced or Metastatic Non-small Cell Lung CancerPhase 2NCT02855125

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

A Phase 2 study testing TAS-114 and S-1 in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Taiho Oncology, Inc. at 30 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAS-114 and S-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
30 sitesin 6 countries
Study dates
29 Aug 2016to 30 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old (≥ 20 years old in Japan);
  • 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;
  • 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
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • Predicted life expectancy of at least 3 months;
Show all 10Show fewer
  • Able to take medications orally;
  • Adequate organ function
  • 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.
  • Willing and able to comply with required scheduled visits and study procedures.

Who cannot join

  • 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.
  • A serious illness or medical condition
  • Concomitant treatment with the following drugs that may interact with S-1:
Show all 11Show fewer
  • 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
  • Known hypersensitivity to S-1 or its metabolites (eg, 5-FU);
  • Previous use of TAS-114, S-1, and 5-FU drugs;
  • A pregnant or lactating female or possibly pregnant women, or men or women wishing to have children during the study period;
  • A judgment of the investigator that the patient is inappropriate for study participation.

Trial locations and contacts

30 sites in 6 countries.

30 sites in 6 countries

Japan7 sites

  • Study site

    Adachi, Saitama, 362-0806

  • Study site

    Chuo-Ku, Tokyo

  • Study site

    Kashiwa, Chiba

  • Study site

    Koto-Ku, Tokyo, 135-8550

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Sunto-Gun, Tokyo

  • Study site

    Wakayama, 641-8509

Other trials in Japan

United States6 sites

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Gainesville, Florida

  • Study site

    Loma Linda, California

  • Study site

    Portland, Oregon

  • Study site

    Seattle, Washington

Other trials in United States

France6 sites

  • Study site

    Caen

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Pierre-Bénite

  • Study site

    Villejuif

Other trials in France

Italy4 sites

  • Study site

    Catania

  • Study site

    Milan

  • Study site

    Palermo

  • Study site

    Ravenna

Other trials in Italy

Poland4 sites

  • Study site

    Katowice

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Warsaw

Other trials in Poland

Spain3 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Madrid

Other trials in Spain

About this study

Official title: 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

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.

Read the 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)
Being tested
TAS-114, S-1
Keywords
NSCLC, phase 2 study, TAS-114, S-1
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS-114Drug

    TAS-114 was a modulator of 5-fluorouracil (5-FU).

  • S-1Drug

    S-1 was designed to provide oral delivery of 5-FU and to reduce the rate of degradation of 5-FU in vivo.

Study groups in NCT02855125
Study groupRoleWhat they receive
TAS-114 + S-1Active comparatorParticipants received 400 milligrams (mg) of TAS-114 tablets orally twice daily (BID) along with 30 milligrams per meter square (mg/m^2) of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks).
Receives: Drug: TAS-114; Drug: S-1
S-1 (Monotherapy)Active comparatorParticipants received 30 mg/m^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks).
Receives: Drug: S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Based on Central Independent Review

    Progression-free survival was defined as the time (in months) from the day of randomization to the start of radiologic disease progression or death (any cause), whichever occurred first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). As per RECIST 1.1 criteria, progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). (Note: the appearance of one or more new lesions was also considered progressions). Participants who did not have disease progression or died were censored at the last known time that the participant was progression free.

    Measured: From date of randomization or until date of disease progression or death whichever occurred first (approximately up to 13 months)

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS was defined as the time from the first dose of the study treatment to death from any cause. Participants who were alive at the end of study were censored at the last date the participant was known to be alive. OS was estimated from Kaplan-Meier method.

    Measured: From date of randomization until death (approximately up to 15 months)

  2. Overall Response Rate (ORR) Based on Central Independent Review

    ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and non-target lesions and normalization of tumor marker level. Any pathological and non-pathological lymph nodes must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters.

    Measured: From date of first dose of study drug to the date of first documentation of progression or death (approximately up to 13 months)

  3. Disease Control Rate (DCR) Based on Central Independent Review

    DCR was defined as the percentage of participants with objective evidence CR, PR, or stable disease (SD). Based on the central review of tumor assessments per RECIST, version 1.1. CR was defined as disappearance of all target lesions. Reduction in any pathological lymph nodes in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameters during study.

    Measured: From date of first dose of study drug to the date of first documentation of progression or death (approximately up to 13 months)

  4. Duration of Response (DR) Based on Central Independent Review

    DR was derived for participants with objective evidence of PR or CR. DR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. Participants who were alive and progression-free as of the analysis cut-off date were censored at their last evaluable tumor response assessment before initiation of any new anticancer treatment.

    Measured: From date of first response to the date of first documentation of progression or death (approximately up to 13 months)

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened during the TEAE period which was defined as the period from the time of first dose of study treatment until 30 days after last dose of study treatment. AEs included both serious and non- serious adverse events.

    Measured: From first dose of study drug up to 30 days after the last dose of study drug (approximately up to 13 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study start29 Aug 2016
  3. Primary completion30 Sep 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855125
Sponsor's protocol ID
TAS-114-201
Other IDs
2016-001806-40, 2016
Status last verified
Aug 2024
First submitted
18 Jul 2016
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yamamoto N, Hayashi H, Planchard D, Moran T, Gregorc V, Dowell J, Sakai H, Yoh K, Nishio M, Cortot AB, Benhadji KA, Soni N, Huang J, Makris L, Cedres S. A randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer. Invest New Drugs. 2020 Oct;38(5):1588-1597. doi: 10.1007/s10637-020-00930-5. Epub 2020 Apr 3.

    PubMed 32246224

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAS-114 and S-1 in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Taiho Oncology, Inc. at 30 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan, United States, France, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Based on Central Independent Review (time frame: From date of randomization or until date of disease progression or death whichever occurred first (approximately up to 13 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02855125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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