Clinical trial NCT04648189: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lung Cancer
Surgery
Circulating Tumor Cell
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2020-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: reduction of circulating tumor cells
timeFrame: From date of registration until CTC measurement at 3 months after surgery.
Secondary outcomes:
measure: the reduction of CTC's in percentage as a continuous variable
timeFrame: From date of registration until CTC measurement at 3 months after surgery.
measure: plasma ability killing tumor cells
timeFrame: From date of registration until CTC measurement at 3 months after surgery.
measure: disease free survival
timeFrame: From date of surgery to until the date of first documented progression or date of death from any cause.
measure: safety
timeFrame: From date of registration until CTC measurement at 3 months after surgery.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - VUMC
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: The Netherlands Cancer Institute-Antoni van Leeuwenhoek
name: Egbert Smit, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marjolein van Egmond, prof
role: PRINCIPAL_INVESTIGATOR
References: