A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Фаза 1/2 – комбинирано ранно изпитване
Заболявания:
Non-Small Cell Lung Cancer
Спонсор: Hoffmann-La Roche
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Кой може да участва
Inclusion Criteria:
* Confirmation of Biomarker eligibility
* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
* No prior systemic treatment for advanced unresectable or metastatic NSCLC
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.
Exclusion Criteria:
* Known concomitant second oncogenic driver with available targeted treatment
* Squamous cell histology NSCLC
* Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
* Prior treatment with a KRAS G12C inhibitor
* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment
* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
* Co-morbid condition that is an absolute contraindication to treatment with corticosteroids
* Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.
* Participants with brain metastases for whom complete surgical resections is clinically appropriate
Интервенции
Divarasib
DRUG
Pembrolizumab
DRUG
Carboplatin
DRUG
Cisplatin
DRUG
Pemetrexed
DRUG
Места на провеждане
71
Argentina (3)
Hospital Britanico
Buenos Aires
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires
Centro Oncologico Riojano Integral (CORI)
La Rioja
Австралия (3)
Concord Repatriation General Hospital
Concord , New South Wales
COMPLETED
Peter MacCallum Cancer Centre
Melbourne , Victoria
Alfred Health
Melbourne , Victoria
Белгия (4)
Cliniques Universitaires St-Luc
Brussels
Jessa Zkh (Campus Virga Jesse)
Hasselt
Clinique Ste-Elisabeth
Namur
AZ Delta (Campus Rumbeke)
Roeselare
Бразилия (2)
Hospital de Cancer de Barretos
Barretos , São Paulo
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo , São Paulo
Канада (3)
Jewish General Hospital
Montreal , Quebec
Ottawa Hospital Regional Cancer Centre
Ottawa , Ontario
Princess Margaret Cancer Center
Toronto , Ontario
ACTIVE_NOT_RECRUITING
Китай (3)
Hunan Cancer Hospital
Changsha
ACTIVE_NOT_RECRUITING
Harbin Medical University Cancer Hospital
Harbin
Shanghai Pulmonary Hospital
Shanghai
ACTIVE_NOT_RECRUITING
Израел (3)
Rambam Medical Center
Haifa
Rabin MC
Petah Tikva
Tel Aviv Sourasky Medical Ctr
Tel Aviv
Италия (4)
Irccs Istituto Nazionale Dei Tumori (Int)
Milan , Lombardy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples , Campania
WITHDRAWN
A.O. Universitaria S. Luigi Gonzaga
Orbassano , Piedmont
Policlinico Universitario Agostino Gemelli IRCCS
Rome , Lazio
ACTIVE_NOT_RECRUITING
Япония (5)
National Cancer Center Hospital East
Chiba
Kindai University Hospital
Osaka
National Cancer Center Hospital
Tokyo
The Cancer Institute Hospital of JFCR
Tokyo
Wakayama Medical University Hospital
Wakayama
Нидерландия (2)
NKI The Netherlands Cancer Institute
Amsterdam
ACTIVE_NOT_RECRUITING
UMC St Radboud
Nijmegen
Полша (3)
Uniwersyteckie Centrum Kliniczne
Gda?sk
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn
ACTIVE_NOT_RECRUITING
Южна Корея (5)
Pusan National University Hospital
Busan
Seoul National University Hospital
Seoul
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Korea University Guro Hospital
Seoul
Испания (6)
ICO Badalona-H.U. Germans Trias i Pujol
Badalona , Barcelona
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen del Rocio
Seville
Hospital Clinico Universitario de Valencia
Valencia
Швеция (1)
Sahlgrenska University Hospital
Gothenburg
Швейцария (2)
Universitätsspital Basel
Basel
Inselspital Bern
Bern
WITHDRAWN
Taiwan (4)
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan Uni Hospital
Taipei
Chang Gung Medical Foundation - Linkou
Taoyuan District
ACTIVE_NOT_RECRUITING
Великобритания (2)
Beatson West of Scotland Cancer Centre
Glasgow
Barts & London School of Med
London
САЩ (16)
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg , Virginia
City of Hope National Medical Center
Duarte , California
WITHDRAWN
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Fort Myers , Florida
MD Anderson Cancer Center
Houston , Texas
City of Hope - Seacliff
Huntington Beach , California
WITHDRAWN
City of Hope at Irvine Lennar
Irvine , California
WITHDRAWN
UCSD Moores Cancer Center
La Jolla , California
WITHDRAWN
City of Hope - Long Beach Elm
Long Beach , California
WITHDRAWN
NYU Langone Hospital - Long Island
Mineola , New York
Yale Cancer Center
New Haven , Connecticut
NYU Cancer Center
New York , New York
Mount SInai Medical Center
New York , New York
Virginia Oncology Associates
Norfolk , Virginia
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg , Florida
Montefiore Medical Center - Montefiore Medical Park