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Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

Primary Purpose

Lung Cancer, Surgery, Circulating Tumor Cell

Status
Withdrawn
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amsterdam UMC - VUMC
  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single dose cetuximab prior to surgery

Arm Description

A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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).

Full Information

First Posted
November 13, 2020
Last Updated
October 17, 2023
Sponsor
The Netherlands Cancer Institute
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT04648189
Brief Title
Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
One of the participating specialties has decided to no longer cooperate in this research
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
September 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Dutch Cancer Society

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Surgery, Circulating Tumor Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose cetuximab prior to surgery
Arm Type
Experimental
Arm Description
A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
Primary Outcome Measure Information:
Title
reduction of circulating tumor cells
Description
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.
Secondary Outcome Measure Information:
Title
the reduction of CTC's in percentage as a continuous variable
Description
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.
Title
plasma ability killing tumor cells
Description
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.
Title
disease free survival
Description
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.
Title
safety
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egbert Smit, prof
Organizational Affiliation
The Netherlands Cancer Institute-Antoni van Leeuwenhoek
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjolein van Egmond, prof
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC - VUMC
City
Amsterdam
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
to be decided

Learn more about this trial

Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

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