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A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

NCT ID: NCT07230691

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-03

Study Completion Date

2030-11-28

Brief Summary

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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).

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Klinikum Klagenfurt am Worthersee

Klagenfurt, , Austria

Site Status RECRUITING

Fakultni nemocnice Brno

Brno, , Czechia

Site Status RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, , Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status RECRUITING

Onkologie am Raschplatz

Hanover, , Germany

Site Status RECRUITING

Klinikum Konstanz

Konstanz, , Germany

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Assuta MC

Tel Aviv, , Israel

Site Status RECRUITING

Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

Bari, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, , Italy

Site Status RECRUITING

ASL Gallura - Ospedale Giovanni Paolo II

Olbia, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria di Sassari

Sassari, , Italy

Site Status RECRUITING

Ospedali Riuniti Di Ancona

Torrette-Ancona, , Italy

Site Status RECRUITING

Countries

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Austria Czechia Germany Israel Italy

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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61186372NSC4014

Identifier Type: OTHER

Identifier Source: secondary_id

61186372NSC4014

Identifier Type: -

Identifier Source: org_study_id