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)

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Begins enrollment this month; Phase 4

Conditions: VTE (Venous Thromboembolism); NSCLC (Advanced Non-small Cell Lung Cancer); Rash Due to Epidermal Growth Factor Receptor Inhibitors; Infusion Reaction

Treatments: Combination Product: Enhanced dermatologic management; Combination Product: Enhanced VTE Prophylaxis (Cohort 1 only); Combination Product: Enhanced IRR Prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT07469488

61186372NSC4015

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

122 participants in 3 patient groups

Cohort 1 (cEGFR 1L)

Experimental group

Description:

Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management

Treatment:

Combination Product: Enhanced IRR Prophylaxis

Combination Product: Enhanced VTE Prophylaxis (Cohort 1 only)

Combination Product: Enhanced dermatologic management

Cohort 2 (cEGFR 2L)

Experimental group

Description:

Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management

Treatment:

Combination Product: Enhanced IRR Prophylaxis

Combination Product: Enhanced dermatologic management

Cohort 3 (EGFR Ex 20ins 1L)

Experimental group

Description:

Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management

Treatment:

Combination Product: Enhanced IRR Prophylaxis

Combination Product: Enhanced dermatologic management