NL-OMON54889
Recruiting
Not Applicable
nraveling tumor response and resistance to combined chemotherapy and PD-L1 inhibition with minimal invasive techniques in patients with advanced NSCLC with targetable disease - Biomarker by minimal invasive techniques of response to chemo-immunotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provision of signed and dated, written informed consent.
- •2\. Female and male subjects aged at least 18 years.
- •3\. Subjects with histologically\- or cytologically\-documented non squamous NSCLC
- •with a documented driver mutation (such as EGFR, ALK, ROS, BRAF, MET, RET,
- •NTRK1\-3, KRAS, NRG1, HER 2\).
- •4\. New (\< 3 month old) tumor specimen (histology or cytology containing enough
- •tumor cells and tumor DNA for at least NGS and PD\-L1 staining confirmed by a
- •pathologist). If the tumor specimen reveals a possible new targetable driver
- •than that has to be discussed with the subject as an option next to this study.
- •5\. Locally advanced or metastatic NSCLC, not amenable to curative surgery or
Exclusion Criteria
- •1\. Treatment with any other investigational agent or participation in another
- •clinical trial with therapeutic intent within 14 days prior to inclusion of the
- •2\. Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
- •anti\*PD\-1, and anti\*PD\-L1 therapeutic antibodies.
- •Patients who have had prior anti\*CTLA\-4 treatment may be enrolled, provided
- •the following requirements are met:
- •o Minimum of 6 weeks from the last dose of anti\*CTLA\-4
- •o No history of severe immune related adverse effects from anti\*CTLA\-4 (CTCAE
- •Grade 3 and 4\).
- •3\. CNS disease, treated brain metastases without the need for steroids are
Outcomes
Primary Outcomes
Not specified
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