Afatinib MET-PET/CT Study

JRCT ID: jRCTs031180271

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small-cell lung carcinoma
• Date of first enrollment: 01/05/2018
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Treatment of afatinib
Evaluation using MET-PET/CT

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hanaoka Masayuki
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd.
• Secondary ID(s): UMIN000031117