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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Enhanced dermatologic management

    Combination product

    1. Systemic protection 2. Scalp protection 3. Body and face hydration 4. Paronychia prevention

  • Enhanced IRR Prophylaxis

    Combination product

    Oral dexamethasone + Standard premedications

  • Enhanced VTE Prophylaxis (Cohort 1 only)

    Combination product

    Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.

Treatment groups

122 Participants
are divided into 3 treatment groups
Group A: Cohort 1 (cEGFR 1L)Experimental treatment 3 interventions
Group B: Cohort 2 (cEGFR 2L)Experimental treatment 2 interventions
Group C: Cohort 3 (EGFR Ex 20ins 1L)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
At 3 months

Secondary outcomes

1

The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL at 6 months

Time frame
At 6 months
2

Safety in Subjects receiving Amivantamab-based regimens

Incidence and severity of treatment-related AEs (TRAEs)

Time frame
12 months
3

Overall response rate (ORR)

Overall response rate (ORR) in Subjects receiving Amivantamab-based regimens

Time frame
12 months
4

Progression-free survival (PFS)

PFS in Subjects receiving Amivantamab-based regimens

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: