FDG-PET/CT and prediction of anti-PD-1/PD-L1 antibody in lung cancer

JRCT ID: jRCTs031180036

Registered date:01/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung cancer
• Date of first enrollment: 01/03/2018
• Target sample size: 58
• Study type: Interventional
• Intervention(s): All patients undergo FDG-PET/CT before and 4 weeks and 9weeks after initiation of anti-PD-1/PD-L1 antibody therapy.

Outcome(s)

Primary Outcome

1)Changeing of SUVmax, MTV and TLG, and the efficacy of anti-PD-1/PD-L1 antibody such as nivolumab or pembrolizumab.

2)Evaluation after 4weeks and 9weeks from administration of anti-PD-1/PD-L1 antibody.

• Secondary Outcome: Overall survival and progression-free survival

Key inclusion & exclusion criteria

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

Include criteria

1)Pathologically confirmed advanced non-small cell lung cancer (NSCLC)
2)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3)Patient with evaluable lesion based on RECIST
4)Written informed consent

Exclude criteria

1)Pregnant woman
2)Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
3)Patients with collagen vascular disease or autoimmune diseases
4)Other cases attending physician it is determined unsuitable for registration of the study

Related Information

• Primary Sponsor: Kaira Kyoichi
• Source(s) of Monetary Support: Nihon Medi-Physics Co., Ltd.
• Secondary ID(s): UMIN00031009