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Trial · NCT00652561

Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

NCT00652561, Phase 2, Completed, Taiho Oncology, Inc.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer. Trials, record NCT00652561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00652561

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer
NCT number
NCT00652561
Status
Completed
Phases
Phase 2
Enrollment
57 participants, actual
Lead sponsor
Taiho Oncology, Inc.
Conditions
Advanced Non-Small Cell Lung Cancer
Interventions
S-1
First posted
2008-04-03
Last updated
2024-09-03

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Tumor assessmentswill be obtained at baseline and at the end of every even cycle
SecondaryTo evaluate the duration of response (DR), and progression-free survival (PFS)
Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Pts will be followed for survival every 2 mos after PD for up to 12 mos from the date of enrollment of the last pt.
SecondaryTo evaluate the safety profile of S-1
Each cycle will last 21 days (14 days treatment, 7 days recovery) until death/removal from study. AEs reported through f/up; blood/urine collected at baseline, Days 8&15, w/in 24 hrs of drug on Day 1 of each cycle after Cycle 1, at end of treatment.
SecondaryTo investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters
Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. s Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00652561

GET https://conductscience.org/api/trials/v1/NCT00652561/registered