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)
A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ironwood Cancer and Research Center β Chandler, Arizona
Age range: 18 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (93 Sites)
Showing the first 25 of 93 sites.
- Ironwood Cancer and Research Center β Chandler, Arizona
- City of Hope β Duarte, California
- Providence Fullerton β Fullerton, California
- Los Angeles Cancer Network β Glendale, California
- City of Hope Seacliff β Huntington Beach, California
- City of Hope Orange County Lennar Foundation Cancer Center β Irvine, California
- City of Hope Long Beach Elm β Long Beach, California
- Cancer and Blood Specialty Clinic β Los Alamitos, California
- Keck Hospital of USC β Los Angeles, California
- USC Norris Oncology Hematology Newport Beach β Newport Beach, California
- Kaiser Permanente Oakland Medical Center β Oakland, California
- Kaiser Permanente Roseville Medical Center β Roseville, California
- Kaiser Permanente San Francisco Medical Center β San Francisco, California
- Kaiser Permanente Santa Clara Medical Center β Santa Clara, California
- City of Hope South Pasadena β South Pasadena, California
- Kaiser Permanente Northern California β Vallejo, California
- Kaiser Permanente Walnut Creek Medical Center β Walnut Creek, California
- University Cancer & Blood Center β Athens, Georgia
- Hope and Healing Care β Hinsdale, Illinois
- Oncology Hematology Associates β Springfield, Missouri
- Renown Health Medical Oncology β Reno, Nevada
- Hunterdon Hematology Oncology β Flemington, New Jersey
- Clinical Research Alliance Inc β Westbury, New York
- Regional Medical Oncology Center β Wilson, North Carolina
- University Hospitals Cleveland Medical Center β Cleveland, Ohio
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- THIO Sequenced With Cemiplimab in Advanced NSCLC β Birmingham, Alabama
- A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions β Duarte, California
- Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study β La Jolla, California
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π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.