A pilot study of pembrolizumab in elderly patients with non-small cell lung cancer

JRCT ID: jRCTs061180068

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 04/10/2017
• Target sample size: 26
• Study type: Interventional
• Intervention(s): Patients will receive intravenous pembrolizumab (200 mg every 3 weeks) for 35 cycles

Outcome(s)

• Primary Outcome: Progression Free Survival

Secondary Outcome

Objective Response Rate
Disease Control Rate
Overall survival
Safety
Quality of life

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) ECOG PS 0 or 1
2) Non-small cell lung cancer
3) Stage IIIB or IV or recurrence
4) PD-L1 tumor proportion score of 50% or greater
5) No sensitizing EGFR mutations or ALK translocations
6) Chemotherapy naive
7) Provided written informed consent
8) With adequate organ function

Exclude criteria

1) Pleural effusion, ascites or pericardial effusion requiring drainage
2) Other cancers
3) Symptomatic brain metastasis and meningitis
4) With severe complication
5) Interstitial pneumonia on CT
6) Severe drug allergy
7) Active autoimmune disease that has required systemic treatment
8) Dementia
9) Other conditions not suitable for this study

Related Information

• Primary Sponsor: Hattori Noboru
• Secondary ID(s): UMIN0000029602