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NCT06120140 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT06120140: Recruiting Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT06120140 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 300 participants, roughly in line with the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06120140, a Phase 2 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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, dermatit
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 |
What NCT06120140 shows while recruiting
NCT06120140 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target.
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.
NCT06120140 names 20 study sites across 5 states, led by California, Arizona, Georgia.
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.
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).
Who is sponsoring clinical trial NCT06120140?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06120140's enrollment target sits among peer trials
300 42nd of 130 higher than 89 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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