NSCLC (Advanced Non-small Cell Lung Cancer)Phase 4AmiCARENCT07469488

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

A Phase 4 study testing Enhanced dermatologic management, Enhanced IRR Prophylaxis and Enhanced VTE Prophylaxis (Cohort 1 only) in people with NSCLC (Advanced Non-small Cell Lung Cancer) and VTE (Venous Thromboembolism), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC (Advanced Non-small Cell Lung Cancer), VTE (Venous Thromboembolism), Rash Due to Epidermal Growth Factor Receptor Inhibitors
What is being tested?: Enhanced dermatologic management, Enhanced IRR Prophylaxis and Enhanced VTE Prophylaxis (Cohort 1 only)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 1 siteChina
Study dates: 30 Apr 2026to 31 Dec 2029
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Shanghai Pulmonary Hospital
Shanghai
Sha Zhao, +86, zhaosha093388@163.com

Other trials in China

About this study

Official title: 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

Conditions: NSCLC (Advanced Non-small Cell Lung Cancer), VTE (Venous Thromboembolism), Rash Due to Epidermal Growth Factor Receptor Inhibitors, Infusion Reaction
Being tested: Enhanced dermatologic management, Enhanced IRR Prophylaxis, Enhanced VTE Prophylaxis (Cohort 1 only)
Keywords: Amivantamab, Lazertinib, NSCLC, EGFR
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07469488
Study group	Role	What they receive
Cohort 1 (cEGFR 1L)	Experimental	Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management Receives: Combination Product: Enhanced dermatologic management; Combination Product: Enhanced IRR Prophylaxis; Combination Product: Enhanced VTE Prophylaxis (Cohort 1 only)
Cohort 2 (cEGFR 2L)	Experimental	Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management Receives: Combination Product: Enhanced dermatologic management; Combination Product: Enhanced IRR Prophylaxis
Cohort 3 (EGFR Ex 20ins 1L)	Experimental	Participants will receive enhanced dermatologic management and enhanced IRR prophylaxis management Receives: Combination Product: Enhanced dermatologic management; Combination Product: Enhanced IRR Prophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL at 6 months
Measured: At 6 months
Safety in Subjects receiving Amivantamab-based regimens
Incidence and severity of treatment-related AEs (TRAEs)
Measured: 12 months
Overall response rate (ORR)
Overall response rate (ORR) in Subjects receiving Amivantamab-based regimens
Measured: 12 months
Progression-free survival (PFS)
PFS in Subjects receiving Amivantamab-based regimens
Measured: 12 Months
12-month PFS rate
12-month PFS in Subjects receiving Amivantamab-based regimens
Measured: 12 months
Time to treatment failure (TTF)
TTF in Subjects receiving Amivantamab-based regimens
Measured: 12 months
Duration of response (DOR)
DOR in Subjects receiving Amivantamab-based regimens
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202631 Dec 2029

First posted13 Mar 2026
Study start30 Apr 2026 (estimated)
Primary completion31 Aug 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 122 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07469488
Sponsor's protocol ID: 61186372NSC4015
Acronym: AmiCARE
Status last verified: Mar 2026
First submitted: 3 Mar 2026
Last updated: 13 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.2025.01.018. Epub 2025 Jan 24.
PubMed 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 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.
PubMed 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. 2023 Nov 30;389(22):2039-2051. doi: 10.1056/NEJMoa2306441. Epub 2023 Oct 21.
PubMed 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, 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.
PubMed 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 Calderon V, de Marinis F, Passaro A, Kim SW, Gadgeel SM, Xie J, Sun T, Martinez M, Ennis M, Fennema E, Daksh M, Millington D, Leconte I, Iwasawa R, Lorenzini P, Baig M, Shah S, Bauml JM, Shreeve SM, Sethi S, Knoblauch RE, Hayashi H; MARIPOSA Investigators. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024 Oct 24;391(16):1486-1498. doi: 10.1056/NEJMoa2403614. Epub 2024 Jun 26.
PubMed 38924756

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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