NIPH Clinical Trials Search

UMIN ID: UMIN000001826

Registered date:31/03/2009

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedAdvanced non-small cell lung cancer
Date of first enrollment2009/04/01
Target sample size860
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Docetaxel alone Docetaxel and S-1


Primary OutcomeOverall survival
Secondary OutcomeProgression free survival Adverse events Response rate

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteria1) 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.

Related Information


public contact
Address Japan
Telephone 075-241-4894
Affiliation The Japan-multinational Trial Organization The Japan-multinational Trial Organization
scientific contact
Name Masaaki Kawahara
Address 1180 Nagasone, Kitaku, Sakai, Osaka, Japan Japan
Telephone 06-6972-1181
Affiliation National Hospital Organization Kinki-chuo Chest Medical Center Internal Medicine