A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chine… (NCT07469488) | Clinical Trial Compass
Not Yet RecruitingPhase 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
China122 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 incl…
What they're measuring
1
The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months
Timeframe: At 3 months
Trial details
NCT IDNCT07469488
SponsorShanghai Pulmonary Hospital, Shanghai, China