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NOT YET RECRUITING
NCT07469488
PHASE4

A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

Summary

This study aims to explore the clinical outcomes of Comprehensive Enhanced Preventive Management (CEPM) combined with an amivantamab-containing treatment regimen in Chinese patients with EGFR-mutated advanced NSCLC.

Official title: AmiCARE: A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2026-04-30

Completion Date

2029-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Enhanced dermatologic management

1. Systemic protection 2. Scalp protection 3. Body and face hydration 4. Paronychia prevention

COMBINATION_PRODUCT

Enhanced IRR Prophylaxis

Oral dexamethasone + Standard premedications

COMBINATION_PRODUCT

Enhanced VTE Prophylaxis (Cohort 1 only)

Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, China