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A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC

A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC - A Multi-center Phase II Clinical trial of 3rd and more line TS-1 treatment for Advanced NSCLC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004295
Enrollment
45
Registered
2010-09-30
Start date
2010-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Interventions

The dosage of TS-1 administers 80mg/m2/day. And, it administers for 14 days, and it takes a rest for seven days afterwards. The treatment period administers more than four courses or disease progr

Sponsors

Ehime University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed Non-Small Cell Lung Cancer 2)Advanced Stage (IV or IIIB) 3)previously treated by chemotherapy and failure 4)The case of prior Radiation therapy is accceptable. But It is necessary to pass for 4 weeks and more since last treatment and recovery adversed event 5)With measurable lesion 6)Oral intake is possible 7)20<=, years 8)Patients who have estimated life expectancy longer than 3 months 9)Performance Status(ECOG):0-2 10)Adequate organ functions 11)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with serious infections or susupected infections with fever 2)complication of massive pericardial effusion, ascites or pleural sffusion 3)uncontrollable heart failure or Interstitial pneumonitis 4)Pregnant or lactating woman 5)Symptomatic brain metastasis 6)Hystory of active double cancer 7)poorly controled diabetes mellitus 8)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Design outcomes

Primary

MeasureTime frame
efficacy (Response Rate(CR+PR),Disease Control Rate(CR+PR+SD)

Secondary

MeasureTime frame
Safety(Adverse events), PFS, OS

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026