Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 24, 2023

Primary Completion Date

January 30, 2026

Study Completion Date

July 31, 2027

Conditions
Metastatic Non-small Cell Lung Cancers
Interventions
DRUG

Amivantamab

Low fucose, fully human immunoglobulin gamma-1-based bispecific antibody directed against EGFR and MET tyrosine kinase receptors. It shows clinical activity against tumors with the primary activating EGFR mutations Exon 19del or Exon 21 L858R substitution, EGFR Exon 20ins mutations, the EGFR resistance mutations Threonine790Methionine (T790M) or Cysteine797Serine (C797S), and activation of the Mesenchymal Epithelial Transition (MET) pathway.

DRUG

Lazertinib

It selectively inhibits both primary activating EGFR mutations (Exon 19del, Exon 21 L858R substitution) and the EGFR T790M resistance mutation, while having less activity versus wild-type EGFR.

DRUG

Pemetrexed 500 mg

Inhibits enzymes involved in folate-dependent metabolism, thereby disrupting cellular replication.

Trial Locations (14)

14784400

Hospital de Amor de Barretos, Barretos

60810-180

Pronutrir - Oncologia e Nutrição, Fortaleza

29308-065

Hospital Evangélico de Cachoeiro de Itapemirim, Cachoeiro de Itapemirim

81520-060

Hospital Erasto Gaertner, Curitiba

59062-000

Liga Norte Riograndense Contra o Câncer, Natal

90050-170

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

91751-443

Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre

14015-010

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto

15090-000

Hospital de Base de São José do Rio Preto, São José do Rio Preto

20230-130

INCA - Instituto Nacional de Câncer, Rio de Janeiro

22250-905

Centro de Tratamento de Tumores Botafogo (Oncoclínicas), Rio de Janeiro

01246-000

ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo

01323-030

BP - A Beneficência Portuguesa de São Paulo, São Paulo

04014-002

São Camilo Oncologia, São Paulo

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER