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

NCT07469488 | Not Yet Recruiting Phase 4

• 1 other identifier: 61186372NSC4015
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer); VTE (Venous Thromboembolism); Rash Due to Epidermal Growth Factor Receptor Inhibitors; Infusion Reaction

Keywords

Amivantamab; Lazertinib; NSCLC; EGFR

Outcome Measures

Primary Outcomes (1)

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

  At 3 months

Secondary Outcomes (7)

• 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

• Overall response rate (ORR)

  12 months

• Progression-free survival (PFS)

  12 Months

• 12-month PFS rate

  12 months

Study Arms (3)

Cohort 1 (cEGFR 1L)

EXPERIMENTAL

Participants will receive enhanced dermatologic management, enhanced IRR and VTE prophylaxis management

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

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

Combination Product: Enhanced dermatologic management; Combination Product: Enhanced IRR Prophylaxis

Interventions

Enhanced dermatologic management COMBINATION_PRODUCT

1. Systemic protection 2. Scalp protection 3. Body and face hydration 4. Paronychia prevention

Cohort 1 (cEGFR 1L); Cohort 2 (cEGFR 2L); Cohort 3 (EGFR Ex 20ins 1L)

Enhanced IRR Prophylaxis COMBINATION_PRODUCT

Oral dexamethasone + Standard premedications

Cohort 1 (cEGFR 1L); Cohort 2 (cEGFR 2L); Cohort 3 (EGFR Ex 20ins 1L)

Enhanced VTE Prophylaxis (Cohort 1 only) COMBINATION_PRODUCT

Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.

Cohort 1 (cEGFR 1L)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

Location

Related Publications (5)

• 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.

  PMID: 39864547 BACKGROUND

• 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.

  PMID: 40923969 BACKGROUND

• 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.

  PMID: 37870976 BACKGROUND

• 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.

  PMID: 37879444 BACKGROUND

• 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.

  PMID: 38924756 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 13, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)