Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation

Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation - Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004807

Enrollment

Registered

2010-12-29

Start date

2011-01-01

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

lung adenocarcinoma

Interventions

gefitinib 250mg/body/day 8weeks surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically confirmed adenocarcinoma (2) resectable with cT1-3N2M0 lung cancer (3) Patients with EGFR mutation (Eexon19 deletion, L858R, L861Q, G719A, G719C, G719S) which is expected the good response with gefitinib (4) Patients who have not previously treated yet (5) ECOG PS 0-1 (6) Sufficient organ functions white blood cell count >=3000/uL platelet count >=100000/uL hemoglobin >= 8.0 g/dl GOT and GPT <= 2.0x upper normal limit serum bilirubin level <= 1.5 mg/dl serum creatinine level <= 1.5 mg/dl PaO2 >= 70 mmHg (7) life expectancy more than 3 month (8) Provided written informed consent

Exclusion criteria

Exclusion criteria: (1) patients who has interstitial pneumonia identified by chest CT or by blood test (2) (3) Patients with EGFR mutation (T790M) which is NOT expected the good response with gefitinib. (4) Patients with uncontrollable complications (5) Pregnant or lactation women, or women with known or suspected pregnancy (6) Patients with severe malabsorption syndrome or with severe functional gastrointestinal disorder (7) patients with systemic administration steroids over 4 weeks (8) Patients with contraindication of gefitinib (9) Patients with active concomitant malignancy (10) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Rate of completion and complications of the protocol treatment	—

Secondary

Measure	Time frame
Rate of response, completion, and complications of neo-adjuvant chemotherapy Rate of complete resection and complications of operation 3-year overall survival disease free survival	—

Countries

Japan

Outcome results

None listed

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