Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Dutch Cancer Society
• Treatments: Cetuximab

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.