NIPH Clinical Trials Search

UMIN ID: UMIN000000539

Registered date:11/12/2006

PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiednon small cell lung cancer
Date of first enrollment2006/03/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: Experimental arm Gefitinib (250mg/day) monotherapy until disease progression B: Reference arm CDDP (80mg/sqm) day1, Docetaxel (60mg/sqm), q3w x 3-6 courses


Primary OutcomeProgression free survival
Secondary OutcomeOverall survival Response

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1. Prior drug therapy targeting EGFR (TKI, Abs) 2. History of interstitial pneumonia or pulmonary fibrosis (Patients with radiation pneumonitis limited to radiation field are eligible) 3. History of severe drug allergy 4. History of active infection or other serious disease condition (GI bleeding, poorly controlled cardiac diseases, cirrhosis, ileus, persistant watery diarrhea, etc.) 5. History of symptomatic brain metastases. Brain metastases necessitating drug therapy for brain edema 6. History of poorly controlled pleural effusion 7. History of pericardial effusion or ascites necessitating drainage 8. History of active double cancer 9. History of severe hypersensitivity to polysolvate 80 containing drugs 10. History of pregnancy or lactation 11. Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Related Information


public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Tetsuya Mitsudomi
Address 377-2 Ohno-Higashi, Osaka-Sayama, Japan Japan
Telephone 072-366-0221
Affiliation Kinki University Faculty of Medicine Division of Thoracic Surgery, Department of Surgery