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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
Search all trials

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
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
Are there results?
Not yet: the study is under way

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.
Show all 19Show fewer
  • 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

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.

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 groupRoleWhat they receive
Cohort 1 (cEGFR 1L)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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.

  1. 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)

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

    Measured: At 6 months

  2. Safety in Subjects receiving Amivantamab-based regimens

    Incidence and severity of treatment-related AEs (TRAEs)

    Measured: 12 months

  3. Overall response rate (ORR)

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

    Measured: 12 months

  4. Progression-free survival (PFS)

    PFS in Subjects receiving Amivantamab-based regimens

    Measured: 12 Months

  5. 12-month PFS rate

    12-month PFS in Subjects receiving Amivantamab-based regimens

    Measured: 12 months

  6. Time to treatment failure (TTF)

    TTF in Subjects receiving Amivantamab-based regimens

    Measured: 12 months

  7. 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.

  1. First posted13 Mar 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07469488, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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