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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Graz
  Graz, Austria Recruiting
• Klinikum Klagenfurt am Worthersee
  Klagenfurt, Austria Recruiting
• Landeskrankenhaus Hochzirl Natters
  Natters, Austria Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• UZ Antwerpen
  Edegem, Belgium Recruiting
• Jessa Ziekenhuis
  Hasselt, Belgium Recruiting

+40 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC

  This study tests whether giving amivantamab together with lazertinib or with carboplatin and pemetrexed before surgery can slow or stop tumor growth in people with resectable EGFR-mutated NSCLC.

  Recruiting at 27 sites Phase 2 Janssen Research & Development, LLC · Duarte, California and 26 other locations · NCT07586202

• Amivantamab plus olomorasib for metastatic KRAS G12C non-small cell lung cancer

  This trial tests whether combining amivantamab and olomorasib can slow tumor growth in people with metastatic non-small cell lung cancer that has a KRAS G12C mutation after platinum chemotherapy and PD‑L1 immunotherapy.

  Recruiting at 12 sites Phase 1/2 Janssen Research & Development, LLC · New York, New York and 11 other locations · NCT07227025

• Combining Amivantamab with Lazertinib or Chemotherapy for Advanced Lung Cancer

  This study tests if a new combination of amivantamab with lazertinib or chemotherapy can help people with advanced lung cancer that has certain genetic changes.

  Recruiting at 68 sites Phase 2 Janssen Research & Development, LLC · Daphne, Alabama and 204 other locations · NCT06667076

• Evaluating amivantamab for advanced non-small cell lung cancer

  This study is testing if a new treatment combining amivantamab and another drug can help people with advanced non-small cell lung cancer, especially those with certain genetic mutations.

  Recruiting at 82 sites Phase 2 Janssen Research & Development, LLC · La Jolla, California and 109 other locations · NCT05498428

• Amivantamab with intrathecal pemetrexed for leptomeningeal metastasis from EGFR-mutated lung adenocarcinoma

  This study tests whether giving amivantamab with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung cancer.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07744529

• Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer

  This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.

  Recruiting at 11 sites Groupe Francais De Pneumo-Cancerologie · Aix-en-Provence and 15 other locations · NCT07563205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.