immunotherapy alone versus immunotherapy-chemotherapy in first line treatment of lung cancer: which treatment works best?
- Conditions
- non small cell lung cancer (NSCLC)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002743-26-NL
- Lead Sponsor
- Paulien van Deutekom Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 84
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Histologically confirmed NSCLC, negative for EGFR and ALK mutations
•WHO PS 0-2
•No prior systemic therapy
•High PD-L-1 expression (=50% TPS)
•High tumor burden (=2 extrapulmonary metastases (M1c)) and not amenable for local consolidative therapies
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 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Patients amenable for local consolidative therapies
•Use of steroids equivalent to >10 mg prednisolon per day prior to start of study
•Untreated brain metastases
•Adequate bone marrow and organ functions (renal and liver)
•Uncontrolled active infections, HIV
•Autoimmune diseases and interstitial lung diseases are to be excluded depending on physicians decision
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method