Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)

Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC) - Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001826

Enrollment

860

Registered

2009-03-31

Start date

2009-04-01

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

Advanced non-small cell lung cancer

Interventions

Docetaxel alone Docetaxel and S-1

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed Non Small Cell Lung Cancer 2) Advanced Stage (IV or IIIB) 3) With measurable lesion 4) One more prior platinum-based chemotherapy 5) Performance Status (ECOG) 0-1 6) )20<=,<75 years 7) Adequate organ functions 8) Patients who have estimated life expectancy longer than 3 month 9) Oral intake is possible 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with serious infections or suspected infections with fever. 2) Pregnant or lactating women 3) Active concomitant malignancy 4) sever allergy 5) Active ineterstitial pneumonitis 6) The prior treatment is a case only of the molecular-targeted agent. 7) Symptomatic brain metastasis 8) History of using 5-FU or docetaxel 9) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression free survival Adverse events Response rate	—

Countries

Japan

Outcome results

None listed

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