Phase II study of necitumumab and pembrolizumab in patients with PD-L1 high-expressing non-small-cell lung cancer
- Conditions
- non-small cell lung cancerPD-L1 high-expressing non-small-cell lung cancer
- Registration Number
- JPRN-jRCT2031200248
- Lead Sponsor
- Horiike Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
We determine patients who are obtained document agreement by free will after the explanation using informed consent form, satisfy all of the following selection criteria, do not conflict with exclusion criteria, have been judged to be eligible for participation in this study by the research doctor as subjects.
1) Histologically confirmed advanced non-small cell lung cancer
2) PD-L1 expression in more than 50% of tumor cells as determined by immunohistochemistry
3) Lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation
4) Measurable lesion by RECIST ver1.1
5) Performance status 0 to 1 (ECOG)
6) Age at agreement acquisition is over 20 years old
7) Life expectancy is at least 3 months
8) Adequate organ function
We exclude persons who corresponding to any of the following criteria from this study.
1) Medical history that may have an impact on the evaluation and safety of this study (heart, liver, kidney, lung , blood disorder etc.)
2) History or complication of autoimmune disease
3) Continuously using systemic corticosteroid
4) Pericardial, pleural effusion or ascites to need drainage
5) Pregnant or lactating women, or men and women with wanting pregnancy
6) Persons who has been judged unsuitable as subjects of this study by the research doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method