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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Treatments tested in this trial

  • Enhanced dermatologic management
  • Enhanced IRR Prophylaxis
  • Enhanced VTE Prophylaxis (Cohort 1 only)

Treatment groups

122 Participants
are divided into 3 treatment groups