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Starting soon Phase 4

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

NCT07469488 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-04-30
Last updated
2026-03-13

Condition(s) studied

NSCLC (Advanced Non-small Cell Lung Cancer)VTE (Venous Thromboembolism)Rash Due to Epidermal Growth Factor Receptor InhibitorsInfusion Reaction

Investigational drug(s) / intervention(s)

Enhanced dermatologic managementEnhanced IRR ProphylaxisEnhanced VTE Prophylaxis (Cohort 1 only)

Enhanced dermatologic management: 1. Systemic protection 2. Scalp protection 3. Body and face hydration 4. Paronychia prevention

Enhanced IRR Prophylaxis: Oral dexamethasone + Standard premedications

Enhanced VTE Prophylaxis (Cohort 1 only): Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months — At 3 months

Trial sites (1)

FacilityCityRegionStatus
Shanghai Pulmonary Hospital Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469488 on ClinicalTrials.gov ↗ ← All trials in China