Lung CancerPhase 2NCT04648189
Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC
A Phase 2 study testing Cetuximab in people with Lung Cancer and Surgery, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
Trial summary
Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Surgery, Circulating Tumor Cell
- What is being tested?
- Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2022to 19 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Amsterdam UMC - VUMC
Amsterdam
Leiden University Medical Center
Leiden
About this study
Official title: Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer
Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC
Read the 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
- Being tested
- Cetuximab
- Medical subject headings
- Lung Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Single dose cetuximab prior to surgery | Experimental | A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
the reduction of CTC's in percentage as a continuous variable will be assesed
Measured: From date of registration until CTC measurement at 3 months after surgery.
plasma ability killing tumor cells
the concentration of plasma who have the ability to inhibit growth in patients treated with cetuximab, ADCP and/or ADCC of tumor cells by cytotoxic immune effector cells
Measured: From date of registration until CTC measurement at 3 months after surgery.
disease free survival
Although this study is not powered for disease free survival, we will conduct follow-up of all the patients in order to get preliminary information about potential clinical efficacy
Measured: From date of surgery to until the date of first documented progression or date of death from any cause.
safety
Safety and toxicity will also be studied. All adverse events and SUSARS will be scored using the common Terminology Criteria for Adverse Events (CTCAE).
Measured: From date of registration until CTC measurement at 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Jan 2022 (estimated)
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Why it stopped: One of the participating specialties has decided to no longer cooperate in this research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Egbert Smit, prof, Principal investigator, The Netherlands Cancer Institute-Antoni van LeeuwenhoekMarjolein van Egmond, prof, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648189
- Sponsor's protocol ID
- M20EGF
- Status last verified
- Oct 2023
- First submitted
- 13 Nov 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be decided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04648189
- Acronym / sponsor ID
- M20EGF
- Conditions
- Lung Cancer, Surgery, Circulating Tumor Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the participating specialties has decided to no longer cooperate in this research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose cetuximab prior to surgery | Experimental | Drug: CetuximabA single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabA single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery | Drug | Single dose cetuximab prior to surgery |
Primary outcome
reduction of circulating tumor cells
Time frame: From date of registration until CTC measurement at 3 months after surgery.
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.
4 secondary outcomes
the reduction of CTC's in percentage as a continuous variable
Time frame: From date of registration until CTC measurement at 3 months after surgery.
plasma ability killing tumor cells
Time frame: From date of registration until CTC measurement at 3 months after surgery.
disease free survival
Time frame: From date of surgery to until the date of first documented progression or date of death from any cause.
safety
Time frame: From date of registration until CTC measurement at 3 months after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Undecided. to be decided
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egbert Smit, prof principal investigator
The Netherlands Cancer Institute-Antoni van Leeuwenhoek
Marjolein van Egmond, prof principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Lung Cancer and Surgery, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of circulating tumor cells (time frame: From date of registration until CTC measurement at 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.