Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

Netherlands Cancer Institute (NKI)

Status and phase

Withdrawn

Phase 2

Conditions

Surgery

Lung Cancer

Circulating Tumor Cell

Treatments

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT04648189

M20EGF

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No 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.