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Clinical outcomes of amivantamab-based treatment for advanced EGFR-mutated non-small cell lung cancer in everyday care.

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

Observational Janssen Research & Development, LLC · NCT07230691

This project will see how amivantamab-containing treatments work for people with advanced non-small cell lung cancer who have common EGFR mutations.

Quick facts

Study typeObservational
Enrollment380 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsamivantamab, lazertinib, chemotherapy
Locations60 sites (Graz and 59 other locations)
Trial IDNCT07230691 on ClinicalTrials.gov

What this trial studies

This observational, real-world project will collect clinical and health-related outcome data from people with advanced NSCLC who have common EGFR mutations (exon 19 deletion or exon 21 L858R) and who are starting an amivantamab-containing regimen. Treatment decisions are made by the treating physician before enrollment and patients must begin the regimen within four weeks of starting data collection. Data will be gathered at participating hospitals in Austria and Belgium and will follow local prescribing information and monitoring practices for amivantamab. No experimental interventions are assigned by the protocol; the study documents effectiveness, safety, and care patterns in routine practice.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed common EGFR-mutated (exon 19 deletion or exon 21 L858R) advanced NSCLC who have a physician-directed plan to start an amivantamab-containing regimen for the first time within four weeks and who can provide informed consent.

Not a fit: Patients without common EGFR mutations, those who already received amivantamab, or those not planning to start an amivantamab-containing regimen are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this work could give doctors clearer real-world information on how well amivantamab-containing regimens work and how safe they are for patients with common EGFR-mutated advanced NSCLC.

How similar studies have performed: Amivantamab has shown clinical activity in other trials and has regulatory approval for certain EGFR-mutant NSCLC subtypes, but real-world outcome data specifically for common EGFR mutations are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion criteria:

* 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)

Where this trial is running

Graz and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell Lung
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.