Improvement of treatment with and dose reduction of pembrolizumab
Phase 1
- Conditions
- non-small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10027412Term: MesotheliomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000493-15-NL
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
Eligible for treatment with pembrolizumab for non small cell lung cancer in line with current ESMO treatment guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Not willing to provide informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The overall main objective is to study the non-inferiority of reduced dose pembrolizumab;Secondary Objective: To develop biomarkers to predict treatment response early in treatment;Primary end point(s): 1-year survival rate;Timepoint(s) of evaluation of this end point: 1 year
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Biomarker predictive performance to predict treatment response;Timepoint(s) of evaluation of this end point: End of trial