Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

NCT ID: NCT04648189

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-09-19

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

Conditions

Lung Cancer; Surgery; Circulating Tumor Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single dose cetuximab prior to surgery

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

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

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

Interventions

Cetuximab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Egbert Smit, prof

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute-Antoni van Leeuwenhoek

Marjolein van Egmond, prof

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Amsterdam UMC - VUMC

Amsterdam, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

M20EGF

Identifier Type: -

Identifier Source: org_study_id