Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC
A multicenter single arm phase II trial. 40 patients with pathology proven stage I-IIIA NSCLC that are eligible for resection will be enrolled in this study. All patients will receive one dose of cetuximab prior to surgery. Blood will be drawn on multiple timepoints to assess te amount of circulating tumor cells
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
Amsterdam UMC - VUMC
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
reduction of circulating tumor cells
The primary objective of this study is to determine whether a single neoadjuvant dose of cetuximab (anti-EGFR mAb) - administered 72 to 48 hours prior to surgery - will reduce the number of CTCs in patients. The reduction of CTCs will be expressed in percentage as more or less than 50% changed from baseline.
Time frame: From date of registration until CTC measurement at 3 months after surgery.
the reduction of CTC's in percentage as a continuous variable
the reduction of CTC's in percentage as a continuous variable will be assesed
Time frame: From date of registration until CTC measurement at 3 months after surgery.
plasma ability killing tumor cells
the concentration of plasma who have the ability to inhibit growth in patients treated with cetuximab, ADCP and/or ADCC of tumor cells by cytotoxic immune effector cells
Time frame: From date of registration until CTC measurement at 3 months after surgery.
disease free survival
Although this study is not powered for disease free survival, we will conduct follow-up of all the patients in order to get preliminary information about potential clinical efficacy
Time frame: From date of surgery to until the date of first documented progression or date of death from any cause.
safety
Safety and toxicity will also be studied. All adverse events and SUSARS will be scored using the common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From date of registration until CTC measurement at 3 months after surgery.
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