A Phase II Study of Pemetrexed and Gefitinib in Chemotherapy Naive Patients with Non-Small Cell Lung Cancer Harboring Mutations of EGFR

A Phase II Study of Pemetrexed and Gefitinib in Chemotherapy Naive Patients with Non-Small Cell Lung Cancer Harboring Mutations of EGFR - Pemetrexed and Gefitinib in Chemotherapy Naive Patients with NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003808

Enrollment

Registered

2010-06-24

Start date

2010-05-01

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

1.Pemetrexed(500mg/m2) Day1 q3weeks Supplementation with folic acid and vitamin B12 2. Gefitinib(250mg) Day2-16 q3weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-squamous, non-small cell lung cancer. 2)NSCLC harboring mutations of EGFR. 3) Stage III, IV 4) Chemothrapy naive patients 5) Performance Status(ECOG Scale): 0-1. 6) Adequate organ function 7) Life expectancy more than 12 weeks. 8) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Using NSAIDs regularly. 2) Interstitial pneumonia/lung fibrosis on chest CT. 3) Previous drug allergy 4) History of poorly controlled pleural effusion, pericardial effusion and ascites. 5) Active infection. 6) Current Diarrhea. 7) Ileus or intestinal tract paralysis. 8) Symptomatic brain metastasis. 9) Active concomitant malignancy. 10) History of sever heart disease. 11) History of sever psychological disease. 12) Hoped to be pregnant/nursing. 13) Those judged to be not suitable by the attending physician.

Design outcomes

Primary

Measure	Time frame
RR:response rate	—

Secondary

Measure	Time frame
PFS: progression free survival OS: overall survival DCR: disease control rate AEs: adverse events	—

Countries

Japan

Contacts

Public ContactNaruo Yoshimura

Graduate School of Medicine, Osaka City University Department of Respiratory Medicine

y-naruo@sc4.so-net.ne.jp06-6645-3793

Outcome results

None listed

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