Clinical trial · Interventional
Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC
Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer
NCT04648189CI-TRIAL-00070623withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): One of the participating specialties has decided to no longer cooperate in this research
Summary
Brief summary (as posted)
Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single dose cetuximab prior to surgery
- description
- A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
- interventionNames
- Drug: Cetuximab
Primary outcomes (1)
- measure
- reduction of circulating tumor cells
- timeFrame
- From date of registration until CTC measurement at 3 months after surgery.
- description
- 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.
Secondary outcomes (4)
- measure
- the reduction of CTC's in percentage as a continuous variable
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.