Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.

Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations. - Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013502

Enrollment

Registered

2014-03-25

Start date

2013-10-04

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

erlotinib 150mg/day orally

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed diagnosis on lung adenocarcinoma. 2)Stage IV or recurrent disease after surgery. 3)Patients harboring active EGFR mutation(exon 19 deletion or L858R) without T790M. 4)Patients with brain metastases confirmed by MRI or CT. 5)The presence of measureable lesion by RECIST. 6)Patients with no prior treatment with EGFR-TKIs. 7)Patients with no prior radiotherapy to brain metastases. 8)Patients with no prior radiotherapy to lung. 9)Age of 20 years or older. 10)Performance Status(ECOG) 0-2. 11)Adequate organ function 12)Interval Palliative radiotherapy >= 2weeks Surgery >= 4weeks Chest or Pericardial drainage>= 2weeks 13)Life expectancy more than 3 months. 14)Written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1)Symptomatic brain metastasis. 2)Patients with untreated brain metastases of size 3cm or more. 3)Active synchronous malignant neoplasm. 4)Uncontrolled pleural effusion, ascites, or pericardial effusion. 5)Active infection requiring systemic administration of antiviral agents, antifungal agents, or antibiotics. 6)Severe complications. 7)Interstitial pneumonia or pulmonary fibrosis detectable on Xray. 8)History of severe drug allergy 9)Patients unable to be treated with oral medication. 10)Pregnancy or lactating patients. 11)Uncontrolled psychotic disease. 12)Patients who were judged inappropriate to entry this study by physician.

Design outcomes

Primary

Measure	Time frame
Event Free Survival: EFS	—

Secondary

Measure	Time frame
Response rate, Response rate of brain metastases, Progression free survival, Overall survival, Local therapy free interval for brain metastases, Duration of treatment with erlotinib	—

Countries

Japan

Contacts

Public ContactAsuka Tsuya

Osaka city General Hospital Department of clinical oncology

a-tsuya@med.osakacity-hp.or.jp06-6929-1221

Outcome results

None listed

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