Phase III study comparing gefitinib with gefitinib combined with carboplatin/pemetrexed for advanced non-small cell lung cancer with EGFR mutation (NEJ009)

Phase III study comparing gefitinib with gefitinib combined with carboplatin/pemetrexed for advanced non-small cell lung cancer with EGFR mutation (NEJ009) - Gefitinib vs Gefitinib plus chemotherapy for EGFR-mutated NSCLC (NEJ009)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006340

Enrollment

340

Registered

2011-10-01

Start date

2011-10-28

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

Non-small cell lung cancer

Interventions

Gefitinib alone until disease progression, unacceptable toxicity, or patient&#39

s refusal Gefitinib/carboplatin/pemetrexed until disease progression, unacceptable toxicity, or patient&#39

s refusal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed non-squamous cell lung cancer harboring sensitive EGFR mutation 2. Chemotherapy naive 3. Having adequate organ functions and good performance status (ECOG PS 0-1) 4. With written informed consent

Exclusion criteria

Exclusion criteria: 1. NSCLC harboring T790M mutation 2. With massive effusion that require drainage 3. With symptomatic brain metastasis 4. With severe co-morbidities 5. With ineligible conditions judged by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival, second PFS in gefitinib alone arm, and Overall survival	—

Countries

Japan

Contacts

Public ContactAkira Inoue

Tohoku University Hospital Department of Respiratory Medicine

akinoue@idac.tohoku.ac.jp022-717-8539

Outcome results

None listed

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