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AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

500 patients around the world

Available in Brazil, United States

Amgen

2Research sites

500Patients around the world

This study is for people with

Solid tumors

Lung cancer

Non-small cell lung carcinoma

To 100 Years

All Gender

: Subprotocol A, B, and C
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.
Homozygous MTAP-deletion.
Able to swallow and retain PO administered study treatment.
Disease measurable as defined by RECIST v1.1.
Histologically or cytologically confirmed diagnosis of NSCLC.
Arm A (AMG 193 + carboplatin + paclitaxel + pembrolizumab): Predominantly squamous histology.
Arm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab): Predominantly non-squamous histology.
Arm C (AMG 193 + pembrolizumab): PD-L1 positive.
Subprotocol B: Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.
Subprotocol C
Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
Brain lesion meeting RANO-BM criteria for measurable disease.

: Subprotocol A, B, and C
Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
History of solid organ transplant.
Major surgery within 28 days of first dose of AMG 193.
Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
Radiation therapy within 28 days of first dose.
Subprotocol A
Autoimmune disease or immunodeficiency disease as defined in the protocol.

Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP

Recruiting

Av. Dr. Arnaldo, 251 - Consolação, São Paulo - SP, 01255-090, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Recruiting

Ijui, 98700-000

SponsorAmgen

Study typeInterventional

Conditions

Solid tumorsNon-small cell lung carcinoma

Requirements

To 100 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06333951