Clinical trial · Interventional
A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens
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
NCT07469488CI-TRIAL-00105404AmiCAREnot yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infusion Reaction | — | UNRESOLVED | — |
| NSCLC (Advanced Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Rash Due to Epidermal Growth Factor Receptor Inhibitors | — | UNRESOLVED | — |
| VTE (Venous Thromboembolism) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced dermatologic management | Combination Product | — | UNRESOLVED |
| Enhanced IRR Prophylaxis | Combination Product | — | UNRESOLVED |
| Enhanced VTE Prophylaxis (Cohort 1 only) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1 (cEGFR 1L)
- description
- Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management
- interventionNames
- Combination Product: Enhanced dermatologic management
- Combination Product: Enhanced IRR Prophylaxis
- Combination Product: Enhanced VTE Prophylaxis (Cohort 1 only)
- type
- EXPERIMENTAL
- label
- Cohort 2 (cEGFR 2L)
- description
- Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management
- interventionNames
- Combination Product: Enhanced dermatologic management
- Combination Product: Enhanced IRR Prophylaxis
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDSpira 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.2025.01.018. Epub 2025 Jan 24. PMID 39864547
- BACKGROUNDCho 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 Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial. J Thorac Oncol. 2025 Oct;20(10):1517-1530. doi: 10.1016/j.jtho.2025.07.117. Epub 2025 Sep 9. PMID 40923969
- BACKGROUNDZhou 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. 2023 Nov 30;389(22):2039-2051. doi: 10.1056/NEJMoa2306441. Epub 2023 Oct 21. PMID 37870976
- BACKGROUNDPassaro 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, Knoblauch RE, Bauml JM, Campelo RG, Cho BC; MARIPOSA-2 Investigators. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Ann Oncol. 2024 Jan;35(1):77-90. doi: 10.1016/j.annonc.2023.10.117. Epub 2023 Oct 23.