Trials / Not Yet Recruiting
Not Yet RecruitingNCT07469488
A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens
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
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer)
- VTE (Venous Thromboembolism)
- Rash Due to Epidermal Growth Factor Receptor Inhibitors
- Infusion Reaction
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-04-30
- Primary completion
- 2029-08-31
- Completion
- 2029-12-31
- First posted
- 2026-03-13
- Last updated
- 2026-03-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07469488. Inclusion in this directory is not an endorsement.