Randomized phase II trial of S-1 plus docetaxel combination versus single-agent docetaxel in platinum-pretreated patients with non-small-cell lung cancer

Randomized phase II trial of S-1 plus docetaxel combination versus single-agent docetaxel in platinum-pretreated patients with non-small-cell lung cancer - Phase II of S-1 plus docetaxel versus docetaxel alone for relapsed non-small-cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000133

Enrollment

Registered

2005-09-12

Start date

2005-09-01

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

platinum-pretreated patients with non-small-cell lung cancer

Interventions

Combination chemotherapy of S-1 and docetaxel Single-agent of docetaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically and/or cytologically proven NSCLC Progression after platinum-based chemotherapy in 1st line Age ≤ 75 ECOG performance status 0 or 1 Measurable disease adequate bone marrow, lung, hepatic, and renal function No prior therapy within four weeks Written informed consent

Exclusion criteria

Exclusion criteria: Active concomitant malignancy Active Interstitial pneumonia Massive effusions Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Inappropriate condition for this study judged by physicians.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
progression-free survival, overall survival, quality of life, adverse events	—

Countries

Japan

Contacts

Public ContactNagio Takigawa

Okayama Lung Cancer Study Group Coordinating Office Department of Respiratory Medicine, Okayama University Hospital

ntakigaw@md.okayama-u.ac.jp086-235-7227

Outcome results

None listed

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