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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505863-35-00
Acronym
61186372NSC2007
Enrollment
15
Registered
2024-03-18
Start date
2024-03-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

Incidence of Grade ≥2 DAEIs (Appendix 17: Dermatologic Adverse Events of Interest: Preferred Terms) in the first 12 weeks after initiation of amivantamab and lazertinib treatment

Interventions

DRUGDoxyderma 50 mg
DRUGMINOCIN 50 mg capsule rigide
DRUGDociton® 10 mg Filmtabletten
DRUGChlorhexidine
DRUGMinocyclin-ratiopharm® 100 mg Hartkapseln
DRUGProtopic 0.1% ointment
DRUGDalacin 10 mg emulsión cutánea
DRUGOpzelura 15 mg/g cream
DRUGDoxy-M-ratiopharm 100 mg tabletės
DRUGTimolol 0
DRUG5 % AT - 1 A Pharma
DRUGClobeGalen 500 Mikrogramm/g Shampoo
DRUGZink Verla® 10 mg

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of Grade ≥2 DAEIs (Appendix 17: Dermatologic Adverse Events of Interest: Preferred Terms) in the first 12 weeks after initiation of amivantamab and lazertinib treatment

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026