Trial · NCT02855125
A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1
NCT02855125, Phase 2, Completed, Taiho Oncology, Inc.; results first posted 2021-12-23
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1. Trials, record NCT02855125. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02855125
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1
- NCT number
- NCT02855125
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 128 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Advanced or Metastatic Non-small Cell Lung Cancer
- Interventions
- TAS-114, S-1
- First posted
- 2016-08-04
- Last updated
- 2024-09-19
- Other registries' IDs
- eudract:2016-001806-40
- Results first posted
- 2021-12-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Based on Central Independent Review | From date of randomization or until date of disease progression or death whichever occurred first (approximately up to 13 months) | 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. |
| Secondary | Overall Survival (OS) | From date of randomization until death (approximately up to 15 months) | 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. |
| Secondary | Overall Response Rate (ORR) Based on Central Independent Review | From date of first dose of study drug to the date of first documentation of progression or death (approximately up to 13 months) | 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. |
| Secondary | Disease Control Rate (DCR) Based on Central Independent Review | From date of first dose of study drug to the date of first documentation of progression or death (approximately up to 13 months) | 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. |
| Secondary | Duration of Response (DR) Based on Central Independent Review | From date of first response to the date of first documentation of progression or death (approximately up to 13 months) | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug up to 30 days after the last dose of study drug (approximately up to 13 months) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Based on Central Independent Review | From date of randomization or until date of disease progression or death whichever occurred first (approximately up to 13 months) | Intent-to-Treat (ITT) population included all participants randomized in the study, regardless of whether they actually received any study treatment (TAS-114 or S-1) or not. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From date of randomization until death (approximately up to 15 months) | ITT population. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Based on Central Independent Review | From date of first dose of study drug to the date of first documentation of progression or death (approximately up to 13 months) | Tumor response (TR) population included all participants randomized in the study, regardless of whether they actually received any study treatment (TAS-114 or S-1) or not; with measurable disease (at least one target lesion) at baseline and with at least one tumor evaluation (participants who had disease progression or had a cancer related death prior to their 1st tumor evaluation were also considered evaluable). | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Based on Central Independent Review | From date of first dose of study drug to the date of first documentation of progression or death (approximately up to 13 months) | TR population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) Based on Central Independent Review | From date of first response to the date of first documentation of progression or death (approximately up to 13 months) | TR population. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug up to 30 days after the last dose of study drug (approximately up to 13 months) | Analysis was performed on As-Treated (AT) population which included all participants who received at least 1 dose of TAS-114 or S-1. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Based on Central Independent Review | TAS-114 + S-1 | 3.65 | 95% Confidence Interval 2.69 to 5.16 | months | |
| Progression-free Survival (PFS) Based on Central Independent Review | S-1 (Monotherapy) | 4.17 | 95% Confidence Interval 2.60 to 6.60 | months | |
| Overall Survival (OS) | TAS-114 + S-1 | 7.92 | 95% Confidence Interval 6.28 to 10.78 | months | |
| Overall Survival (OS) | S-1 (Monotherapy) | 9.82 | 95% Confidence Interval 7.66 to 13.40 | months | |
| Overall Response Rate (ORR) Based on Central Independent Review | TAS-114 + S-1 | 19.7 | 95% Confidence Interval 10.6 to 31.8 | percentage of participants | |
| Overall Response Rate (ORR) Based on Central Independent Review | S-1 (Monotherapy) | 10.3 | 95% Confidence Interval 3.9 to 21.2 | percentage of participants | |
| Disease Control Rate (DCR) Based on Central Independent Review | TAS-114 + S-1 | 80.3 | 95% Confidence Interval 68.2 to 89.4 | percentage of participants | |
| Disease Control Rate (DCR) Based on Central Independent Review | S-1 (Monotherapy) | 75.9 | 95% Confidence Interval 62.8 to 86.1 | percentage of participants | |
| Duration of Response (DR) Based on Central Independent Review | TAS-114 + S-1 | 3.38 | 95% Confidence Interval 2.37 to 4.86 | months | |
| Duration of Response (DR) Based on Central Independent Review | S-1 (Monotherapy) | NA | 95% Confidence Interval 2.79 to NA | months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS-114 + S-1 | 64 | |
| Overall Study | STARTED | S-1 (Monotherapy) | 64 | |
| Overall Study | Treated | TAS-114 + S-1 | 64 | |
| Overall Study | Treated | S-1 (Monotherapy) | 63 | |
| Overall Study | COMPLETED | TAS-114 + S-1 | 0 | |
| Overall Study | COMPLETED | S-1 (Monotherapy) | 0 | |
| Overall Study | NOT COMPLETED | TAS-114 + S-1 | 64 | |
| Overall Study | NOT COMPLETED | S-1 (Monotherapy) | 64 |
Source ClinicalTrials.gov
Adverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | TAS-114 + S-1 | 42 | 64 | 111 |
| other | Anaemia | Blood and lymphatic system disorders | S-1 (Monotherapy) | 17 | 63 | 26 |
| other | Neutropenia | Blood and lymphatic system disorders | TAS-114 + S-1 | 5 | 64 | 14 |
| other | Neutropenia | Blood and lymphatic system disorders | S-1 (Monotherapy) | 1 | 63 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TAS-114 + S-1 | 4 | 64 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | S-1 (Monotherapy) | 2 | 63 | 5 |
| other | Lacrimation increased | Eye disorders | TAS-114 + S-1 | 5 | 64 | 5 |
| other | Lacrimation increased | Eye disorders | S-1 (Monotherapy) | 5 | 63 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | TAS-114 + S-1 | 3 | 64 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | S-1 (Monotherapy) | 5 | 63 | 5 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS-114 + S-1 | 36 | 64 |
| Total, all-cause mortality | S-1 (Monotherapy) | 29 | 63 |
| Total, other adverse events | TAS-114 + S-1 | 64 | 64 |
| Total, other adverse events | S-1 (Monotherapy) | 61 | 63 |
| Total, serious adverse events | TAS-114 + S-1 | 30 | 64 |
| Total, serious adverse events | S-1 (Monotherapy) | 19 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32246224 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAS-114 + S-1 vs S-1 (Monotherapy): deaths from any cause | Trial comparisons |
| TAS-114 + S-1 vs S-1 (Monotherapy): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02855125
GET https://conductscience.org/api/trials/v1/NCT02855125/events?page=2