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Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

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ClinicalTrials.gov Identifier: NCT04648189
Recruitment Status : Not yet recruiting
First Posted : December 1, 2020
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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

Condition or disease Intervention/treatment Phase
Lung Cancer Surgery Circulating Tumor Cell Drug: Cetuximab Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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




Primary Outcome Measures :
  1. reduction of circulating tumor cells [ Time Frame: From date of registration until CTC measurement at 3 months after surgery. ]
    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.


Secondary Outcome Measures :
  1. the reduction of CTC's in percentage as a continuous variable [ 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 will be assesed

  2. plasma ability killing tumor cells [ Time Frame: From date of registration until CTC measurement at 3 months after surgery. ]
    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

  3. disease free survival [ Time Frame: From date of surgery to until the date of first documented progression or date of death from any cause. ]
    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

  4. safety [ Time Frame: From date of registration until CTC measurement at 3 months after surgery. ]
    Safety and toxicity will also be studied. All adverse events and SUSARS will be scored using the common Terminology Criteria for Adverse Events (CTCAE).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648189


Contacts
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Contact: Egbert Smit, prof +3120512 ext 9111 e.f.smit@nki.nl
Contact: Marianne Mahn, MSc +3120512 ext 9111 m.mahn@nki.nl

Locations
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Netherlands
Amsterdam UMC - VUMC
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Contact: Frank Borm, MSc         
Contact: Jasper Smit, MSc         
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Investigators
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Principal Investigator: Egbert Smit, prof The Netherlands Cancer Institute-Antoni van Leeuwenhoek
Principal Investigator: Marjolein van Egmond, prof Amsterdam UMC
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT04648189    
Other Study ID Numbers: M20EGF
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be decided

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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
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplastic Cells, Circulating
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents