Phase
Condition
Lung Cancer
Non-small Cell Lung Cancer
Cancer
Treatment
BG-60366
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFRactivating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI)
Phase 1a general inclusion criteria:
Disease progression on prior third-generation EGFR-TKI for advanced ormetastatic disease, and either progressed or ineligible for currently availablestandard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKItreatment
Phase 1a safety expansion
Documentation of EGFR resistance mutations (ie, C797s)
At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) perRECIST v1.1
EGFR resistance mutations may be detected locally either from tumor tissue orcirculating tumor DNA (ctDNA) in blood, and samples used for detection of resistancemutations must be collected after progression on the most recent systemic antitumortreatment
Adequate organ function
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Exclusion
Exclusion Criteria:
Any previous histologic or cytologic evidence of small cell or combined smallcell/non-small cell disease in the archival tumor tissue or tumor biopsy beforeenrollment
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 weeksbefore first dose of study drug)
Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targetingchimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with themechanism 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 noninfectiouspneumonitis ≤ 2 years before the first dose of study drug, or has currentILD/noninfectious pneumonitis, or where suspected active ILD/noninfectiouspneumonitis cannot be ruled out by imaging during screening
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequentdrainage
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaActive - Recruiting
Princess Alexandra Hospital
Brisbane, Queensland 4102
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Cancer Research South Australia
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400
BrazilSite Not Available
Liga Norte Riograndene Contra O Cancer
Natal, 59062-000
BrazilSite Not Available
Hospital Sao Lucas Da Pucrs
Porto Alegre, 90610-000
BrazilSite Not Available
Hospital Sao Rafael (Rede Dor)
Salvador, 41253-190
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto, 15090-000
BrazilSite Not Available
Hospital Israelita Albert Einstein
Sao Paulo, 05652-900
BrazilSite Not Available
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Sao Paulo, 01246-000
BrazilSite Not Available
Hospital Santa Rita de Cassia Afecc
Vitoria, 29043-260
BrazilSite Not Available
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong 510120
ChinaActive - Recruiting
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning, Guangxi 530201
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi 030032
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
Hangzhou, Zhejiang 310018
ChinaActive - Recruiting
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, 40138
ItalySite Not Available
Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia
Monza, 20900
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalySite Not Available
Chungbuk National University Hospital
SeowonGu CheongjuSi, Chungcheongbukdo 28644
Korea, Republic ofSite Not Available
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofSite Not Available
Sarawak General Hospital
Kuching, 93586
MalaysiaSite Not Available
Harbour Cancer and Wellness
Auckland, 1023
New ZealandActive - Recruiting
Hospital Universitario Vall Dhebron
Barcelona, 08035
SpainSite Not Available
H Puerta de Hierro Majadahonda
Madrid, 28222
SpainSite Not Available
Hospital Universitario de Octubre
Madrid, 28041
SpainSite Not Available
H Puerta de Hierro Majadahonda
Majadahonda, 28222
SpainSite Not Available
Ramathibodi Hospital Mahidol University
Bangkok, 10400
ThailandSite Not Available
Vajira Hospital
Bangkok, 10300
ThailandSite Not Available
Ramathibodi Hospital Mahidol University
Dusit, 10300
ThailandSite Not Available
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110
ThailandSite Not Available
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
ThailandSite Not Available
University of Colorado
Denver, Colorado 80202-1702
United StatesSite Not Available
University of Miami
Miami, Florida 33136-2107
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215-5418
United StatesActive - Recruiting
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri 63110-1032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065-6800
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210-1132
United StatesSite Not Available
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United StatesActive - Recruiting
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