Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer

JRCT ID: jRCT1011200014

Registered date:10/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 10/12/2020
• Target sample size: 22
• Study type: Interventional
• Intervention(s): 18F-FDG PET/CT and liquid biopsy are performed 6 week after initiation of therapy with pembrolizumab

Outcome(s)

• Primary Outcome: To evaluate the discriminative power of the change of SUVmax, which is obtained via PET/CT 6 week after the initiation of pembrolizumab treatment.
• Secondary Outcome: same analysis using liquid biopsy.

Key inclusion & exclusion criteria

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

Include criteria

1. Previously untreated with chemotherapy
2. Patients more than 20 years old
3. Treated with pembrolizumab (combined with or without chemotherapy)
4. Appropriate physical status
5. Obtained informed consent

Exclude criteria

1. Small-cell carcinoma or unknown
2. Positive for EGFR mutation, ALK fusion, Ros-1 fusion, and BRAF mutation
3. Ever treated with chemotherapy or radiotherapy
4. Poor physical status
5. Severe complication
6. Fasting blood glucose over 150 mg/dl
7. Unable to perform 18F-FDG PET/CT or CT because of complications
8. Other inappropriate patients

Related Information

• Primary Sponsor: Takeuchi Satoshi