A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.

A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations. - A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003274

Enrollment

Registered

2010-03-01

Start date

2010-04-01

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

Non-small cell lung cancer

Interventions

gefitinib with concurrent radiation therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Unresectable locally advanced NSCLC 2.Histologically or cytologically confirmed NSCLC 3.Patients harboring EGFR mutations (exon 19 deletion or L858R) 4.No prior medication (chemotherapy, radiation therapy or surgery) and stage IIIA or IIIB. 5.ECOG performance status (PS): 0-1 6. V20 <= 35% 7.Patients aged 20 years old or older 8.Adequate organ function. WBC count >= 4,000/mm3, Neutrophil count >= 2,000/mm3 Platelet count >= 100,000/mm3 hemoglobin >= 9.5g/dL AST and ALT <= 100 IU/L Bilirubine level <= 1.5 mg/dL Serum creatinine <= 1.2 mg/dL PaO2 >= 70 torr 9.Patients who are considered to survive for more than 3 months 10.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with active severe infections 2.Significant interstitial pneumonitis , pulmonary fibrosis on Chest CT 3.Contralateral hilar lymph node metastasis 4.Patietns with ileus 5.Patients with uncontrollable diarrhea 6.The presence of other concomitant cancers 7.Serious allergy history 8.Patients with total gastrectomy 9.Heavy smoking habit: (the number of cigarettes smoked daily) x (smoking period)> 400 10.Tumor infiltrating great vessels clearly 11.Patients harboring T790M mutation 12.Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Adverse event rates,Response rate,Disease control rate, Progression free survival, Two-year survival rate	—

Countries

Japan

Contacts

Public ContactKazuhiro Asami

National Hospital Organization Kinki-chuo Chest Medical Center Medical oncology

072-252-3021

Outcome results

None listed

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