Infusion Reaction, NSCLC (Advanced Non-small Cell Lung Cancer), Rash Due to Epidermal Growth Factor Receptor Inhibitors, VTE (Venous Thromboembolism)
Conditions
Keywords
Amivantamab, Lazertinib, NSCLC, EGFR
Brief 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.
Interventions
COMBINATION_PRODUCTEnhanced IRR Prophylaxis
Oral dexamethasone + Standard premedications
COMBINATION_PRODUCTEnhanced VTE Prophylaxis (Cohort 1 only)
Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.
COMBINATION_PRODUCTEnhanced dermatologic management
1. Systemic protection 2. Scalp protection 3. Body and face hydration 4. Paronychia prevention
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months | At 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL at 6 months | At 6 months | — |
| Safety in Subjects receiving Amivantamab-based regimens | 12 months | Incidence and severity of treatment-related AEs (TRAEs) |
| Overall response rate (ORR) | 12 months | Overall response rate (ORR) in Subjects receiving Amivantamab-based regimens |
| Progression-free survival (PFS) | 12 Months | PFS in Subjects receiving Amivantamab-based regimens |
| 12-month PFS rate | 12 months | 12-month PFS in Subjects receiving Amivantamab-based regimens |
| Time to treatment failure (TTF) | 12 months | TTF in Subjects receiving Amivantamab-based regimens |
| Duration of response (DOR) | 12 months | DOR in Subjects receiving Amivantamab-based regimens |
Countries
China
Outcome results
None listed