A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation - A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006273

Enrollment

Registered

2011-09-02

Start date

2011-09-01

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

Non-Small Cell Lung Cancer

Interventions

Level 1 gefitinib250mg/day and pemetrexed (300mg/m2) Level 2 gefitinib250mg/day and pemetrexed (400mg/m2) Level 3 gefitinib250mg/day and pemetrexed (500mg/m2) If none of the 3 patients who had b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histology/cytology-proven non-small cell lung cancer, age of 70 years or over 2)NSCLC harboring mutations of EGFR 3)Stage IIIB, IV 4)Chemotherapy na&iuml;ve patients 5)Performance status(ECOG): 0-1 6)Adequate organ function 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Serious infections 2)Serious clinical problems 3)Interstitial pneumonia/lung fibrosis on chest CT 4)Active concomitant malignancy 5)Symptomatic brain metastasis 6)Massive pericardial, pleural effusion, ascites 7)Previous drug allergy 8)Those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD) of pemetrexed and gefitinib	—

Secondary

Measure	Time frame
Anti tumor efficacy	—

Countries

Japan

Contacts

Public ContactMasao Ichiki

National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine

ichiki@kyumed.jp092-852-0700

Outcome results

None listed

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