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Carcinoma, Non-Small-Cell LungPhase 2AFACETNCT03727724

Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

A Phase 2 study testing Afatinib and Cetuximab in people with Carcinoma, Non-Small-Cell Lung, run by The Netherlands Cancer Institute at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single arm open-label multi-center phase II study, investigating disease control rate after 18 weeks of treatment with afatinib/cetuximab combination therapy in patients with advanced non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Afatinib and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
4 sitesNetherlands
Study dates
4 Dec 2018to 6 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

  • Pathologically or cytologically confirmed stage IV non-small cell lung cancer, harboring an EGFR exon 20 insertion mutation.
  • 18 years or older at time of study entry.
  • Life expectancy of at least three months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 1).
  • Measurable disease, according to RECIST 1.1.
  • At baseline adequate fresh or archived tissue from a histological biopsy or a cellblock obtained by fine needle aspiration of a tumor lesion that is not radiated prior to biopsy, must be available. Baseline tissue samples must have been obtained after the last line of systemic therapy prior to study entry.
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  • Adequate normal organ and marrow function as defined below:
  • Absolute leukocyte count ≥ 3 x 109/L (> 3000 per mm3)
  • Platelet count ≥ 75 x 109/L (>75,000 per mm3)
  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤ 3 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x upper limit of normal (ULN).
  • Serum creatinine clearance >30 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
  • Women of child-bearing potential: these subjects must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective contraception, as defined in section 5.2.2, from 7 days prior to enrollment, throughout the treatment period and for seven months after completion of the treatment with cetuximab.
  • Males must agree to take appropriate precautions to avoid fathering a child from the first dose of study treatment through 3 months after the final administration of investigational drugs.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Ability to give written informed consent before patient registration.

Who cannot join

  • Participation in another clinical study with an investigational product during the last 2 weeks.
  • Prior treatment with EGFR targeting antibodies (prior treatment with EGFR TKI's is allowed).
  • Other active malignancy.
  • History of hypersensitivity to afatinib or cetuximab.
  • Major surgery (excluding diagnostic procedures e.g. mediastinoscopy or video assisted thoracic surgery (VATS) biopsy) within 28 days of the start of study treatment.
  • Radiotherapy less than two weeks prior to the start of study treatment.
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  • Symptomatic brain metastases.
  • Breast feeding is not allowed during study treatment.
  • Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, myocardial infarction within 12 months prior to the study entry, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety and anti-tumor activity of the test drugs.

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Antoni van Leeuwenhoek

    Amsterdam, North Holland, 1066 CX

  • VU Medical Center

    Amsterdam, 1007 MB

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Maastricht UMC+

    Maastricht, 6229 HX

Other trials in Netherlands

About this study

Official title: Phase II Single Arm Study of Afatinib in Combination With Cetuximab in EGFR Exon 20 Insertion Positive Non-small-cell Lung Cancer

This is a single arm open-label multi-center phase II study, investigating disease control rate after 18 weeks of treatment with afatinib/cetuximab combination therapy in patients with advanced non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion.

Being tested
Afatinib, Cetuximab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03727724
Study groupRoleWhat they receive
Afatinib plus cetuximabExperimentalAfatinib, 40 mg once daily, orally. Cetuximab, 500 mg/m² intravenously, every 2 weeks. Treatment will be continued until tumor progression (according RECIST v1.1) confirmed by tumor imaging, unacceptable toxicity, or death occurs.
Receives: Drug: Afatinib; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate after 18 weeks

    To determine the disease control rate at 18 weeks of afatinib and cetuximab treatment in patients with NSCLC harboring an EGFR exon 20 insertion mutation.

    Measured: 18 weeks

Secondary outcomes (5)

  1. Objective tumor response

    Objective tumor response (complete response and partial response)determined by RECIST v1.1.

    Measured: Scans every 6 weeks until tumor progression, start of another treatment or death.

  2. Safety (intensity and incidence of adverse events)

    Safety as indicated by intensity and incidence of adverse events, graded according to NCI CTCAE Version 4.03.

    Measured: Up to 30 days after last study drug intake.

  3. Duration of response (DOR)

    Time from documentation of tumor response to disease progression

    Measured: Scans every 6 weeks until tumor progression

  4. Progression free survival

    Time from the date of start treatment to the date of the first documented tumor progression as determined by RECIST1.1, or death due to any cause

    Measured: Until progression, every 6 weeks up to progression

  5. Overall survival

    Time form date of start treatment to the date of death from any cause

    Measured: Every 6 weeks up to death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2018
  2. Study start4 Dec 2018
  3. Primary completion6 Sep 2022
  4. Study completion6 Sep 2022

Resources

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03727724
Sponsor's protocol ID
M18ACX
Acronym
AFACET
Status last verified
Oct 2023
First submitted
3 Sep 2018
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afatinib and Cetuximab in people with Carcinoma, Non-Small-Cell Lung, run by The Netherlands Cancer Institute at 4 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 15 inclusion and 9 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: finished, as of the sponsor's last update on 18 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 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disease control rate after 18 weeks (time frame: 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03727724.

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 18 Oct 2023.

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