Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation

Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation - Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005086

Enrollment

Registered

2011-02-15

Start date

2011-02-01

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

Interventions

Induction therapy with gefitinib Cisplatin and docetaxel with concurrent thoracic radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Non small-cell lung cancer proven cytologically or histologically 2) Patients having EGFR mutation (exon 19 deletion or L858R) 3) treatment naive c-stage IIIA or IIIB 4) Patient who has measurable lesion by RECIST. 5) V20 in radiation field <= 35% 6) oral intake possible 7) Performance status (ECOG)0-2. 8) age 20-74 years old 9) adequate organ functions(within 2 weeks before registration) 1. WBC >= 3,500/mm3 2. Neu >= 2,000/ mm3 3. Plt >= 100,000/ mm3 4. Hb >= 9.0g/dl 5. AST and ALT, x 2 of upper limit of normal (ULN) or less 6. T-Bil < 1.5mg/dl 7. Serum creatinin, x 1.5 of ULN or less creatinine clearance>=60ml/min 8. SpO2 or blood gas SpO2 >= 90% or PaO2 >= 60 torr 9. Lung function 1 second amount More than 1.5L 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients having EGFR gene mutation (T790M) 2) Past history of drug hypersensitivity 3) Patients with superior vena cava (SVC) syndrome 4) pulmonary fibrosis or interstitial pneumonitis evident on chest CT 5) serious heart dosease 6) Psychiatric disorder 7) uncontrollable diabetes 8) paresis of intestine, intestinal obstruction 9) Patients with active severe infections 10) serious complications other 11) Patients with active concomitant malignancy 12) Pregnant or lactation women, or women with known or suspected pregnancy 13) Inappropriate to entry by physician

Design outcomes

Primary

Measure	Time frame
Two year survival rate	—

Secondary

Measure	Time frame
Survival time, progression free survival time, five year survival rate, completion rate of protocol therapy, response rate of induction therapy, response rate of chemoradiation, site and type of progression, incidence of adverse events, correlation between radiation field and survival, correlation between protein expression of molecular marker; ERCC1, RRM1, BRCA1, TSP1, TXR1, thioredoxin, and efficacy or safety	—

Measure

Time frame

Survival time, progression free survival time, five year survival rate, completion rate of protocol therapy, response rate of induction therapy, response rate of chemoradiation, site and type of progression, incidence of adverse events, correlation between radiation field and survival, correlation between protein expression of molecular marker; ERCC1, RRM1, BRCA1, TSP1, TXR1, thioredoxin, and efficacy or safety

—

Countries

Japan

Contacts

Public ContactSho Saeki

Kumamoto University hospital Department of Respiratory Medicine

saeshow@wg7.so-net.ne.jp096-373-5012

Outcome results

None listed

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