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Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis

Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis - Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007020
Enrollment
32
Registered
2012-01-05
Start date
2012-04-27
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

Erlotinib

Sponsors

Lung Oncology Group in Kyushu, Japan (LOGIK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed Non-small cell lung cancer(NSCLC) 2)Previously treated (prior Gefitinib treatment is allowed) 3)Cytologically confirmed carcinomatous meningitis associated with NSCLC 4)Age>=20years 5)ECOG PS 1-3 6)Adequate organ functions 1.WBC >= 3000 /mm3 2.Plt > 75000 /mm3 3.AST and ALT <= 100 IU/ml 4.T-Bil <= 1.5 mg/dl 5.SpO2 >= 90% 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Prior elrotinib treatment with the exception of elrotinib discontinuation for four weeks or more at study enrollment. 2)Active interstitial pneumonia or pulmonary fibrosis on chest CT scan 3)Severe drug allergy 4)Prior radiotherapy to chest within 2 weeks 5)Massive pleural effusion, ascites or pericardial effusion 6)Active infection 7)Continuous watery diarrhea 8)Intestinal paralysis or ileus 9)Symptomatic ophthalmologic disease 10)Current or previous (within the last 1 year) gastrointestinal perforation 11)Severe ulcer 12)Severe cardiac disease 13)Severe psychological disease 14)Pregnant or breast-feeding females or those who declined contraception 15)Inappropriate patients for this study judged by the attending physician

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Overall survival Meningitis progression free survival Adverse event Examination of cerebrospinal fluid Performance status Quality of life

Countries

Japan

Contacts

Public ContactKaname Nosaki

National Kyushu Cancer Center Department of Thoracic Oncology

nosaki.k@nk-cc.go.jp092-541-3231

Outcome results

None listed

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