Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study

Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study - Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000408

Enrollment

Registered

2006-04-24

Start date

2006-02-01

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 with EGFR mutation

Interventions

Oral administration of 250 mg/day of gefitinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed NSCLC 2) With measurable or evaluable disease 3) Postoperative recurrent disease 4) With EGFR mutation of exon 19 or 21 in cancer tissue 5) >= 4weeks after prior treatment 6) ECOG PS 0-1 7) Expected survival over 3 months 8) Sufficient organ functions white blood cell count >=3000/uL neutrophil count >=1500/uL platelet count >=100000/uL hemoglobin >= 8.5 g/dl GOT and GPT < 2.5x upper normal limit serum bilirubin level <= 1.5 mg/dl serum creatinine level <= 1.5 mg/dl PaO2 >= 60 mmHg 9) Provided written informed consent

Exclusion criteria

Exclusion criteria: 1)EGFR mutations except exon19 deletion and exon21 mutation (L858R) or double mutation. 2)Serious infectious disease 3) Brain metastases requiring treatment 4) Serious concomitant disease 5) Ascites, pleural or pericardeal effusion requiring drainage 6)Pregnant or lactation women, or women with known or suspected pregnancy 7) Apparent ineterstitial pneumonia or pulmonary fibrosis 8) Prior treatment of gefitinib 9) Requiring emergency radiotherapy Cardiac infarction within 6 month 10)Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
tumor response rate	—

Secondary

Measure	Time frame
1)Adverse events 2)Progression free-survival 3)Overall survival	—

Countries

Japan

Contacts

Public ContactShinichi Toyooka

Okayama University Cancer and Thoracic Surgery

s_toyooka@nigeka2.hospital.okayama-u.ac.jp086-235-7265

Outcome results

None listed

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