Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer

Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer - Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer (CATS Trial) (CATS Trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000608

Enrollment

600

Registered

2007-04-01

Start date

2007-04-01

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

Stage IIIB/IV or ppstoperative recurrent non-small sell lung cancer

Interventions

CDDP: 80mg/m2 day1 Docetaxel: 60mg/m2 day1 q3-4weeks Doc(60mg/m2) day8 TS-1(800mg/m2) day1-21 q4-5weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed NSCLC 2.Oral intake is possible 3.Stage IIIB or IV and recurrence after operation 4.With measurable or assessable legion(s) 5.Age of 20 to 74-year old 6.PS(ECOG)0 or 1 7.Without prior anti-tumor therapy 8.Preserved organ functions 8.Adequate bone marrow,hepatic and renal function 9.Written IC 10.Life expectancy longer than 12 weeks

Exclusion criteria

Exclusion criteria: 1.With adjuvant chemotherapy 2.History of serious drug allergy 3.Active concomitant malignancy 4.Serious complications 5.Proven or suspected infections diseases 6.Symptomatic brain metastasis 7.Watery diarrhea or Chronic constipation 8.Pleural effusion,peritoneal fluid,and pericardial fluid 9.Concomitant therapy with another anticancer drug or flucytocine 10.Pregnancy,breast feeding or wish of future bearing 11.Mental disease or psychotic manifestation 12.It participated in the development clinical trial of and others within 1 month 13.Other conditions not suitable for this study

Design outcomes

Secondary

Measure	Time frame
PFS TTF Response rate Adverse event QOL	—

Primary

Measure	Time frame
overall survival	—

Countries

Japan

Outcome results

None listed

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