Spots Global Cancer Trial Database for Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations
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Trial Identification
Brief Title: Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations
Official Title: A Single Arm, Phase 2 Study of Amivantamab, Lazertinib and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers (NSCLCs) With EGFR Mutations
Study ID: NCT05299125
Conditions
Study Description
Brief Summary: This is a phase II, single-arm, multicenter trial, conducted through Latin American Coorperative Oncology Group (LACOG). Treatment-naïve patients with recurrent/metastatic NSCLCs harboring EGFR exon 19 deletions or exon 21 L858R point mutations will be enrolled. At baseline, an archival or (optional) new tissue sample will be obtained for biomarker evaluation, as well as liquid biopsies. Treatment will continue until disease progression or unacceptable toxicity.
Detailed Description: This study aims to test the hypothesis that delivery of maximum therapy consisting of lazertinib plus amivantamab plus chemotherapy as frontline treatment in patients with recurrent/metastatic NSCLC with EGFR exon 19 or exon 21 mutations will be feasible, safe, and will improve PFS compared to historical controls. If successful, this study may allow for the estimation of efficacy and toxicity of a three drug regimen of amivantamab, lazertinib, and pemetrexed and may support further evaluation of maximum therapy against osimertinib single agent, lazertinib single agent, osimertinib plus chemotherapy, and/or lazertinib plus amivantamab.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pronutrir - Oncologia e Nutrição, Fortaleza, Ceará, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim, Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital Erasto Gaertner, Curitiba, Paraná, Brazil
Liga Norte Riograndense Contra o Câncer, Natal, Rio Grande Do Norte, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor de Barretos, Barretos, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto, São Paulo, Brazil
Hospital de Base de São José do Rio Preto, São José do Rio Preto, São Paulo, Brazil
INCA - Instituto Nacional de Câncer, Rio de Janeiro, , Brazil
Centro de Tratamento de Tumores Botafogo (Oncoclínicas), Rio de Janeiro, , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo, , Brazil
BP - A Beneficência Portuguesa de São Paulo, São Paulo, , Brazil
São Camilo Oncologia, São Paulo, , Brazil
Contact Details
Name: William Nassib William Junior
Affiliation: Latin American Cooperative Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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