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Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
NCT06120140 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (\>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management and with modified enhanced dermatologic management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib. The study also includes Expansion cohorts (in 2 different schedules) to evaluate enhanced dermatologic management and early intervention for DAEIs or paronychia, in participants receiving subcutaneous amivantamab and lazertinib. A substudy will enroll participants from Arms A and B who experience specific new-onset or persistent DAEIs (Grade \>=2) during treatment with intravenous (IV) amivantamab and lazertinib. This substudy aims to assess the reactive use of dermatologic treatment strategies in these participants.
Conditions Studied
Interventions
- DRUG Lazertinib
- DRUG Doxycycline
- DRUG Amivantamab IV
- DRUG Amivantamab SC
- DRUG Minocycline
Study Locations (20)
California
- City of Hope — Duarte
- Providence Fullerton — Fullerton
- Los Angeles Cancer Network — Glendale
- City of Hope Seacliff — Huntington Beach
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine
- City of Hope Long Beach Elm — Long Beach
- Cancer and Blood Specialty Clinic — Los Alamitos
- Keck Hospital of USC — Los Angeles
- USC Norris Oncology Hematology Newport Beach — Newport Beach
- Kaiser Permanente Oakland Medical Center — Oakland
- Kaiser Permanente Roseville Medical Center — Roseville
- Kaiser Permanente San Francisco Medical Center — San Francisco
- Kaiser Permanente Santa Clara Medical Center — Santa Clara
- City of Hope South Pasadena — South Pasadena
- Kaiser Permanente Northern California — Vallejo
- Kaiser Permanente Walnut Creek Medical Center — Walnut Creek
Arizona
- Ironwood Cancer and Research Center — Chandler
Georgia
- University Cancer & Blood Center — Athens
Illinois
- Hope and Healing Care — Hinsdale
Missouri
- Oncology Hematology Associates — Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-02-16 |
| Est. Completion | 2032-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06120140
The ClinicalTrials.gov registry entry for NCT06120140 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 5 interventions — of which Lazertinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06120140 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06120140 about?
NCT06120140 is a clinical study titled "Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib". The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (\>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management and with modified enhanced dermatologic management in p...
What is the current status of trial NCT06120140?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2024-02-16. Estimated completion is 2032-01-31.
What conditions does trial NCT06120140 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06120140?
The interventions under investigation include: Lazertinib (DRUG), Doxycycline (DRUG), Amivantamab IV (DRUG), Amivantamab SC (DRUG), Minocycline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06120140?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06120140 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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