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)

March 9, 2026 updated by: Ren Shengxiang, Shanghai Pulmonary Hospital, Shanghai, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
  • Participants have a confirmed diagnosis of locally advanced or metastatic EGFR-mutated NSCLC (Stage IIIB/C or IV).
  • Participant [and/or their legally authorized representative where applicable] must sign an ICF allowing source data verification in accordance with local requirements and indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study.
  • Participants have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
  • Participants with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed.
  • Be eligible for, and agree to comply with, the use of enhanced dermatologic management and enhanced IRR prophylaxis management during the duration of anticancer treatments with amivantamab and lazertinib, or amivantamab with chemotherapy.

Cohort 1 (cEGFR 1L):

  • EGFR mutation must be an Ex19del or Ex21 L858R substitution.
  • Participants who plan to receive Amivantamab (IV form) and Lazertinib regimen treatment based on physician's medical judgement.
  • Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease.
  • Be eligible for, and agree to comply with, the use of prophylactic-dose anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of anticancer treatment (from Day 1-120) according to Chinese Society of Clinical Oncology (CSCO) guidelines.

Cohort 2 (cEGFR 2L):

  • EGFR mutation must be an Ex19del or Ex21 L858R substitution.
  • Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement.
  • Participants must have progressed on or after prior therapy including an EGFR TKI for advanced or metastatic NSCLC. Amivantamab and chemotherapy will be received as a second-line treatment.

Cohort 3 (EGFR Ex20ins 1L):

  • EGFR mutation must be an EGFR Ex20ins.
  • Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement.
  • Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy for is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Is currently enrolled in an interventional clinical study.
  • Any condition for which, at the investigator's discretion, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (cEGFR 1L)
Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management
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.
Experimental: Cohort 2 (cEGFR 2L)
Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
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
Experimental: Cohort 3 (EGFR Ex 20ins 1L)
Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months
Time Frame: At 3 months
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL at 6 months
Time Frame: At 6 months
At 6 months
Safety in Subjects receiving Amivantamab-based regimens
Time Frame: 12 months
Incidence and severity of treatment-related AEs (TRAEs)
12 months
Overall response rate (ORR)
Time Frame: 12 months
Overall response rate (ORR) in Subjects receiving Amivantamab-based regimens
12 months
Progression-free survival (PFS)
Time Frame: 12 Months
PFS in Subjects receiving Amivantamab-based regimens
12 Months
12-month PFS rate
Time Frame: 12 months
12-month PFS in Subjects receiving Amivantamab-based regimens
12 months
Time to treatment failure (TTF)
Time Frame: 12 months
TTF in Subjects receiving Amivantamab-based regimens
12 months
Duration of response (DOR)
Time Frame: 12 months
DOR in Subjects receiving Amivantamab-based regimens
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61186372NSC4015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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