A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer

A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer - A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007189

Enrollment

Registered

2012-02-01

Start date

2011-10-01

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

non-small cell lung cancer

Interventions

TS-1 is given in a dose of 40-60 mg/m2 (adjusted to body surface area) twice daily (morning and evening) for 14 consecutive days followed by a 7-day rest. This 3-week period is regarded as one cycle.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirned advanced non-small-cell lung cancer (NSCLC) 2)stage IV or postoperative recurrence patients 3)more than 20 years old 4)Patients previously treated with platinum- based chemotherapy for four cycles and except PD cases 5)ECOG PS 0-1 6)Adequate organ function 7)Signed informed consent 8)patients who can take orally

Exclusion criteria

Exclusion criteria: 1)With fruolouracil based chemotherapy 2)with EGFR TKI therapy 3)patients who will take bevacizumab maintenance therapy 4)Symptomatic brain metastases 5)Pleural effusion, peritoneal fluid, and pericardial fluid 6)Suffers from an infectious disease to need antibiotic treatment 7)Watery diarrhea 8)Serious complications 9)Active concomitant malignancy 10)Pregnancy, breast feeding or wish of future bearing 11)Mental disease or psychotic manifestation 12)History of hypersensitivity against UFT 13) Concomitant therapy with flucytocine 14)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
Adherence at four course, safety, QOL, quality adjusted progression free year, proportion of the second-line therapy	—

Countries

Japan

Contacts

Public ContactKazuo Kasahara

Kanazawa University Hospital Respiratory Medicine

Outcome results

None listed

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