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
Condition(s) studied
Investigational drug(s) / intervention(s)
Amivantamab IV: Amivantamab will be administered.
Amivantamab SC: Amivantamab will be administered as SC injection.
Lazertinib: Lazertinib tablet will be administered orally.
Doxycycline: Doxycycline tablet will be administered orally.
Minocycline: Minocycline capsule will be administered orally.
Clindamycin: Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine: Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer: Noncomedogenic skin moisturizer will be used as topical application.
Ruxolitinib: Ruxolitinib will be used to the affected skin area.
Tacrolimus: Tacrolimus will be used as topical application to the affected skin area.
Zinc gluconate: Zinc gluconate tablet will be administered.
Propranolol: Propranolol tablet will be administered.
Timolol: Timolol will be used to the affected skin area.
Clobetasol: Clobetasol shampoo will be used on the scalp.
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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment — Up to 12 weeks after initiation of anticancer treatment
Number of participants with Grade \>= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.
Trial sites (93)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer and Research Center | Chandler | Arizona | |
| City of Hope | Duarte | California | |
| Providence Fullerton | Fullerton | California | |
| Los Angeles Cancer Network | Glendale | California | |
| City of Hope Seacliff | Huntington Beach | California | |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | |
| City of Hope Long Beach Elm | Long Beach | California | |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | |
| Keck Hospital of USC | Los Angeles | California | |
| USC Norris Oncology Hematology Newport Beach | Newport Beach | California | |
| Kaiser Permanente Oakland Medical Center | Oakland | California | |
| Kaiser Permanente Roseville Medical Center | Roseville | California | |
| Kaiser Permanente San Francisco Medical Center | San Francisco | California | |
| Kaiser Permanente Santa Clara Medical Center | Santa Clara | California | |
| City of Hope South Pasadena | South Pasadena | California | |
| Kaiser Permanente Northern California | Vallejo | California | |
| Kaiser Permanente Walnut Creek Medical Center | Walnut Creek | California | |
| University Cancer & Blood Center | Athens | Georgia | |
| Hope and Healing Care | Hinsdale | Illinois | |
| Oncology Hematology Associates | Springfield | Missouri | |
| Renown Health Medical Oncology | Reno | Nevada | |
| Hunterdon Hematology Oncology | Flemington | New Jersey | |
| Clinical Research Alliance Inc | Westbury | New York | |
| Regional Medical Oncology Center | Wilson | North Carolina | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| Valley Medical Center | Renton | Washington | |
| Gundersen Health System | West Salem | Wisconsin | |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | |
| IADT Instituto Argentino de Diagnostico y Tratamiento | CABA | Argentina | |
| Centro Medico Austral | Capital Federal | Argentina | |
| Hospital Italiano de La Plata | La Plata | Argentina | |
| Hospital Privado de la Comunidad | Mar del Plata | Argentina | |
| CTO Centro De Tratamento Oncologico LTDA | Belém | Brazil | |
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | Brazil | |
| Liga Paranaense de Combate ao Cancer | Curitiba | Brazil | |
| Fundacao Doutor Amaral Carvalho | Jaú | Brazil | |
| Hospital Nossa Senhora da Conceicao S A | Porto Alegre | Brazil | |
| Nucleo de Oncologia da Bahia Oncoclinicas | Salvador | Brazil | |
| Hospital Ana Nery Santa Cruz do Sul | Santa Cruz do Sul | Brazil |
+ 53 more sites — see the full list on the official registry below.
On this site
📄 Jakafi (ruxolitinib) drug profile →More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06120140 on ClinicalTrials.gov ↗ ← All trials in Spain