Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer

Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer; Surgery; Circulating Tumor Cell
• Intervention / Treatment: Drug: Cetuximab

Detailed Description

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
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC - VUmc
  • Leiden, Netherlands
    • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• Presence of surgically resectable NSCLC, stage I-IIIA, with curative intent surgery planned.
• ≥10 EGFR+EpCAM+ cells detected in the baseline blood sample.
• Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug

Exclusion Criteria:

• Chemotherapy or other anti-cancer therapy including radiotherapy during the study or within 4 weeks prior to the start of the study.
• Prior anti-EGFR mAb therapy
• Other currently active malignancy
• Immunosuppressive drugs during the study or within 4 weeks prior to the start of te study
• Expected adverse reactions/allergies or study medication
• Mental disorder/unable to give informed consent
• Pregnancy or breast-feeding patients
• Significant skin condition interfering with treatment
• Major surgery within 28 days before start of study.
• Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
• Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose cetuximab prior to surgery; A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery	Drug: Cetuximab; A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of registration until CTC measurement at 3 months after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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).	From date of registration until CTC measurement at 3 months after surgery.

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Dutch Cancer Society
• Investigators: Principal Investigator: Egbert Smit, prof, The Netherlands Cancer Institute-Antoni van Leeuwenhoek; Principal Investigator: Marjolein van Egmond, prof, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2022
• Primary Completion (Actual): September 19, 2022
• Study Completion (Actual): September 19, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Neoplastic Cells, Circulating; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: M20EGF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: to be decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No