A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer - A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000035

Enrollment

600

Registered

2005-09-04

Start date

2004-04-01

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 Non-small cell lung cancer

Interventions

Platinum doublet chemotherapy more than 3 cycles up to 6 cycles. Platinum doublet chemotherapy 3 cycles followed by gefitinib except PD cases.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed NSCLC Stage IIIB/IV No prior treatment Measurable disease ECOG PS 0-1 Adequate organ function Age 20-74 Written informed consent

Exclusion criteria

Exclusion criteria: Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Countries

Japan

Outcome results

None listed

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