Randomized Phase III Trial Comparing Gefitinib with Carboplatin/Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations

Randomized Phase III Trial Comparing Gefitinib with Carboplatin/Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations - Gefitinib vs CBDCA/TXL in untreated NSCLC with EGFR mutations

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000376

Enrollment

320

Registered

2008-12-31

Start date

2006-04-01

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 with Epidermal Growth Factor Receptor Gene Mutations

Interventions

Gefitinib Carboplatin/Paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically proven NSCLC 2.With EGFR gene mutations 3.With measurable lesion (RECIST) 4.With no prior chemotherapy 5.PS (ECOG) 0 or 1 6.With adequate organ functions 7.With life expectancy over 3 months 8.With written informed consent

Exclusion criteria

Exclusion criteria: 1.With lung fibrosis detectable in chest CT 2.With gefitinib resistant EGFR mutation (T790M) 3.With symptomatic brain metastasis 4.Previous radiotherapy to primary lung cancer 5.With severe co-morbidities 6.With active double cancer

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival, response rate, toxicity, Quality of Life	—

Countries

Japan

Outcome results

None listed

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