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

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт Enhanced dermatologic management
  1. Systemic protection 2. Scalp protection 3. Body and face hydration 4. Paronychia prevention
• Комбинированный продукт Enhanced IRR Prophylaxis
  Oral dexamethasone + Standard premedications
• Комбинированный продукт Enhanced VTE Prophylaxis (Cohort 1 only)
  Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.

Первичные конечные точки

• The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months [Срок оценки: At 3 months]

Вторичные конечные точки (7)

• The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL at 6 months [Срок оценки: At 6 months]
• Safety in Subjects receiving Amivantamab-based regimens [Срок оценки: 12 months]
• Overall response rate (ORR) [Срок оценки: 12 months]
• Progression-free survival (PFS) [Срок оценки: 12 Months]
• 12-month PFS rate [Срок оценки: 12 months]
• Time to treatment failure (TTF) [Срок оценки: 12 months]
• Duration of response (DOR) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Pulmonary Hospital — Шанхай

Публикации

• Spira AI, Paz-Ares L, Han JY, Shih JY, Mascaux C, Roy UB, Zugazagoitia J, Kim YJ, Chiu CH, Kim SW, Nadal E, Gil-Bazo I, Murphy SP, Anderson BG, Xia Y, Wang G, Bauml JM, Chioda M, Simoes J, Mahadevia PJ, Lopes G. Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report. J Thorac Oncol. 2025 Jun;20(6):809-816. doi: 10.1016/j.jtho.2025. PMID 39864547
• Cho BC, Li W, Spira AI, Sauder M, Feldman J, Bozorgmehr F, Mak M, Smith J, Voon PJ, Liu B, Tian P, Tan JL, Yang CT, Shih JY, Karadurmus N, Cundom JE, Bertollo G, Cicin I, Nieva J, Ortega-Granados AL, Tomasini P, Nguyen D, Felip E, Schuchard J, Murphy SP, Anderson BG, Romero T, Xia Y, Sheng S, Bauml JM, Mahadevia PJ, Kam J, Nematian-Samani M, Simoes J, Wildgust M, Girard N. Enhanced Versus Standard PMID 40923969
• Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, Kitazono S, Thiagarajan M, Goldman JW, Sabari JK, Sanborn RE, Mansfield AS, Hung JY, Boyer M, Popat S, Mourao Dias J, Felip E, Majem M, Gumus M, Kim SW, Ono A, Xie J, Bhattacharya A, Agrawal T, Shreeve SM, Knoblauch RE, Park K, Girard N; PAPILLON Investigators. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 20 PMID 37870976
• Passaro A, Wang J, Wang Y, Lee SH, Melosky B, Shih JY, Wang J, Azuma K, Juan-Vidal O, Cobo M, Felip E, Girard N, Cortot AB, Califano R, Cappuzzo F, Owen S, Popat S, Tan JL, Salinas J, Tomasini P, Gentzler RD, William WN Jr, Reckamp KL, Takahashi T, Ganguly S, Kowalski DM, Bearz A, MacKean M, Barala P, Bourla AB, Girvin A, Greger J, Millington D, Withelder M, Xie J, Sun T, Shah S, Diorio B, Knoblau PMID 37879444
• Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourao Dias J, Besse B, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Yang JC, Thomas M, Nguyen D, Ou SI, Mukhedkar S, Prabhash K, D'Arcangelo M, Alatorre-Alexander J, Vazquez Limon JC, Alves S, Stroyakovskiy D, Peregudova M, Sendur MAN, Yazici O, Califano R, Gutierrez Ca PMID 38924756

Идентификаторы

NCT: NCT07469488 · 61186372NSC4015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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