Last updated 4 days ago
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
93 patients around the world
Available in Brazil
BeiGene
8Research sites
93Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI).Disease progression on prior third-generation EGFR-TKI for advanced or metastatic disease, and either progressed or ineligible for currently available standard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKI treatment.Documentation of EGFR resistance mutations (ie, C797s).At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1 measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) per RECIST v1.1.EGFR resistance mutations may be detected locally either from tumor tissue or circulating tumor DNA (ctDNA) in blood, and samples used for detection of resistance mutations must be collected after progression on the most recent systemic antitumor treatment.Adequate organ function.Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Any previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease in the archival tumor tissue or tumor biopsy before enrollment.Symptomatic spinal cord compression.Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug).Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs).Any history of interstitial lung disease (ILD) or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
Sites
Hospital de Câncer de Barretos - Fundação PIO XII
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Hospital Sao Rafael
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Hospital Israelita Albert Einstein - Fortaleza, Ceara
Hospital Santa Rita
SponsorBeiGene
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06685718
