Skip to content

Multicenter, prospective interventional study to evaluate therapeutic effect of Afatinib in patients with advanced non-small cell lung cancer, EGFR mutation positive and brain metastasis

Multicenter, prospective interventional study to evaluate therapeutic effect of Afatinib in patients with advanced non-small cell lung cancer, EGFR mutation positive and brain metastasis - Afatinib MET-PET/CT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031117
Enrollment
20
Registered
2018-02-03
Start date
2018-03-19
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 Cancer

Interventions

Treatment of afatinib Evaluation using MET-PET/CT

Sponsors

First Department of Internal Medicine, Shinshu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed diagnosis of non-squamous cell and non-small cell lung cancer 2)Stage IV advanced unresectable, postoperative recurrent cancer 3)To detect following mutations by analysis of tissue or cell sample 4)Deletion in exon19 or L858R point mutation in exon 21 of EGFR gene 5)Brain metastasis verified by MRI or CT and >= 10 mm measurably 6)Using afatinib as first line treatment. 7)Age >= 20 years at obtained informed consent 8)ECOG performance status 0-2 9)The function of organs (marrow,liver,kidney,etc.)is maintained enough 10)Life expectancy >= 3 months

Exclusion criteria

Exclusion criteria: 1)Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug pneumonia, etc. are complicated 2)Active other malignancy 3)Adjuvant chemotherapy 4)Infection to need to treat with antibiotics or antifungal agent via intravenous administration

Design outcomes

Primary

MeasureTime frame
To evaluate amino acid metabolic reactions obtained by followings To evaluate MET-PET/CT at baseline (SUVmax,L/N ratio) To evaluate MET-PET/CT at 4 and 8 weeks after start of therapy (SUVmax,L/N ratio)

Secondary

MeasureTime frame
To evaluate relationship between amino acid metabolic reactions and following points PFS OS Response rate TTF Disease control rate

Countries

Japan

Contacts

Public ContactKazunari Tateishi

Shinshu University First Department of Internal Medicine

tateishi@shinshu-u.ac.jp+81-263-37-2631

Outcome results

None listed

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