ML41176 Unraveling tumor response and resistance to combined chemotherapy and PD-L1 inhibition with minimal invasive techniques in patients with advanced NSCLC with targetable disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: on-small cell lung cancer (NSCLC) with a documented driver mutation (EGFR, ALK, ROS, BRAF, MET, RET, NTRK).
Sponsor: niversity Medical Center Groningen
Enrollment: 100
Status: Not yet recruiting
Last Updated: 2 years ago

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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\)
•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).
•Confirmation of sufficient adequate tumor material by the central reviewing pathologist (Wim Timens) is required before start.
•5\.Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
•6\.Evidence of radiological disease progression following first line TKI or any subsequent treatment lines with TKI only (for EGFR treated with either osimertinib or failure of other TKIs 2nd line or later). Previous
•course of chemotherapy is allowed, but not necessary as well.
•7\.ECOG performance status 0\-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
•8\.At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as \= 10mm in the longest diameter (except for

•1\.Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to inclusion of the study.
•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:
•\-Minimum of 6 weeks from the last dose of anti\-CTLA\-4
•\-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 allowed.
•4\.Leptomeningeal disease.
•5\.Uncontrolled tumor\-related pain.
•\-Patients requiring pain medication must be on a stable regimen at study entry.
•\-Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment. Patients should be recovered from the effects