Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

NCT04648189 | Withdrawn Phase 2

• 1 other identifier: M20EGF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lung Cancer; Surgery; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of registration until CTC measurement at 3 months after surgery.

Secondary Outcomes (4)

• the reduction of CTC's in percentage as a continuous variable

  From date of registration until CTC measurement at 3 months after surgery.

• plasma ability killing tumor cells

  From date of registration until CTC measurement at 3 months after surgery.

• disease free survival

  From date of surgery to until the date of first documented progression or date of death from any cause.

• safety

  From date of registration until CTC measurement at 3 months after surgery.

Study Arms (1)

Single dose cetuximab prior to surgery

EXPERIMENTAL

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

Drug: Cetuximab

Interventions

Cetuximab DRUG

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

Single dose cetuximab prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Dutch Cancer Society: collaborator

Study Sites (2)

Amsterdam UMC - VUMC

Amsterdam, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplastic Cells, Circulating

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Egbert Smit, prof

  The Netherlands Cancer Institute-Antoni van Leeuwenhoek

  PRINCIPAL INVESTIGATOR

• Marjolein van Egmond, prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 1, 2020
• Study Start: January 1, 2022
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

NL (2)