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Observes outcomes of amivantamab treatment in lung cancer with EGFR mutations

Studies how amivantamab-based treatments work in adults with advanced EGFR-mutated lung cancer.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Brussels, Edegem, Hasselt, Kortrijk, La Louvière, Liège, and Sint-Niklaas, BelgiumSee the 7 sitesAlso in 7 other countries, 83 sites
Trial code
Registry title
A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting
Status
Recruiting
People taking part
380 people, planned
Started
3 Dec 2025
Expected to end
17 Dec 2030
Type of study
Observational, 2 groups
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced lung cancer (non-small cell) with a common EGFR change, who are about to start a treatment containing amivantamab for the first time.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced non-small cell lung cancer (NSCLC) with a confirmed common EGFR mutation (exon 19 deletions or exon 21 L858R substitution)
Earlier treatment
Must be planned to start an amivantamab-containing treatment for the first time within 4 weeks. Must not have had amivantamab before in a clinical trial or compassionate use. One cycle of platinum-based chemotherapy is allowed before the first dose while awaiting biopsy results.
Biomarker or test result
EGFR exon 19 deletions or exon 21 L858R substitution

Main reasons for not taking part

  • Receiving another active cancer treatment for advanced NSCLC that is not part of the approved amivantamab combination
  • Already treated with amivantamab in a clinical trial or for compassionate use
  • Treated with a biosimilar or non-original biologic instead of amivantamab
  • Has a condition listed as a contraindication in the amivantamab product information, or for lazertinib, platinum or pemetrexed

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Participant has a confirmed diagnosis of common epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) (EGFR exon 19 deletions or exon 21 L858R substitution) and is eligible for an amivantamab-containing regimen per the judgment of the treating physician and in alignment with the approved amivantamab indications and recommended prophylactic and reactive medication as described in the local specific summary of product characteristics (SmPC) for amivantamab
  • Participants or their legally acceptable representative, where applicable, must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements
  • Participant is being planned to be initiated with an amivantamab-containing regimen for the first time within 4 weeks following the visit for start of data collection
  • Decision to administer an amivantamab-containing regimen has been made prior to participant's enrollment in the study and is separate from the physician's decision to include the participant in the current study

Who cannot take part

  • At the time of the initiation of the amivantamab-containing regimen, the participant is receiving an active systemic anticancer treatment for advanced NSCLC that is not included in the locally approved combination regimen with amivantamab (regardless of whether it is part of an interventional study). One cycle of platinum-based chemotherapy (for example, carboplatin-pemetrexed) is permitted prior to the first dose of amivantamab in a 1L while awaiting biopsy results
  • Participant has received prior treatment with amivantamab in a clinical trial or for compassionate use
  • Participants who are not receiving amivantamab but are being treated with a biosimilar or a non-original biologic agent
  • Participants with conditions listed in the contraindications of the SmPC for amivantamab or other agents essential for the applicable amivantamab-containing treatment regimen (lazertinib/ platinum/ pemetrexed)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?

Where in Belgium

Also in 7 other countries, 83 sites

  • UZ BrusselBrussels, BelgiumTaking people
  • UZ AntwerpenEdegem, BelgiumTaking people
  • JESSA ZiekenhuisHasselt, BelgiumTaking people
  • AZ GroeningeKortrijk, BelgiumTaking people
  • Chu Helora Hospital La Louviere Site JolimontLa Louvière, BelgiumTaking people
  • CHU de LiègeLiège, BelgiumTaking people
  • VitazSint-Niklaas, BelgiumTaking people

About the trial

What the trial wants to find out

The purpose of this study is to describe the clinical and health-related outcomes of amivantamab-containing regimens for the treatment of common epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC; most common type of lung cancer) in a real-world setting. Metastatic NSCLC is when this disease spreads to other parts of body. NSCLC may occur due to mutations (changes) in many genes including epidermal growth factor receptor (EGFR).

The 2 groups in the trial

  • Cohort B: Amivantamab with carboplatin and pemetrexed

    Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI, who received at least 1 dose of amivantamab in combination with carboplatin and pemetrexed, as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study.

  • Cohort C: Amivantamab and lazertinib

    Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (first-line therapy) who received at least 1 dose of amivantamab in combination with lazertinib as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective, Multi Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice
Plain-language title
Observes outcomes of amivantamab treatment in lung cancer with EGFR mutationsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07230691, who can take part
Record updated
3 November 2026