A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope National Medical Center
RECRUITING
Duarte
City of Hope - Seacliff
RECRUITING
Huntington Beach
City of Hope at Irvine Lennar
RECRUITING
Irvine
UCSD Moores Cancer Center
WITHDRAWN
La Jolla
City of Hope - Long Beach Elm
RECRUITING
Long Beach
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Florida
Florida Cancer Specialists - SOUTH - SCRI - PPDS
RECRUITING
Fort Myers
Florida Cancer Specialists - NORTH - SCRI - PPDS
RECRUITING
St. Petersburg
Florida Cancer Specialists - EAST - SCRI - PPDS
RECRUITING
West Palm Beach
New York
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Mount SInai Medical Center
RECRUITING
New York
NYU Cancer Center
RECRUITING
New York
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Oncology & Hematology Associates of Southwest Virginia, Inc
RECRUITING
Blacksburg
Virginia Oncology Associates
RECRUITING
Norfolk
Other Locations
Argentina
Hospital Britanico
RECRUITING
Buenos Aires
Clinica Adventista Belgrano
RECRUITING
Ciudad Autonoma Buenos Aires
Centro Oncologico Riojano Integral (CORI)
RECRUITING
La Rioja
Australia
Concord Repatriation General Hospital
COMPLETED
Concord
Alfred Health
RECRUITING
Melbourne
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Belgium
Cliniques Universitaires St-Luc
RECRUITING
Brussels
Jessa Zkh (Campus Virga Jesse)
RECRUITING
Hasselt
Clinique Ste-Elisabeth
RECRUITING
Namur
AZ Delta (Campus Rumbeke)
RECRUITING
Roeselare
Brazil
Hospital de Cancer de Barretos
RECRUITING
Barretos
Instituto do Cancer do Estado de Sao Paulo - ICESP
RECRUITING
São Paulo
Canada
Jewish General Hospital
RECRUITING
Montreal
Ottawa Hospital Regional Cancer Centre
RECRUITING
Ottawa
Princess Margaret Cancer Center
ACTIVE_NOT_RECRUITING
Toronto
China
Hunan Cancer Hospital
ACTIVE_NOT_RECRUITING
Changsha
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Shanghai Pulmonary Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Israel
Rambam Medical Center
RECRUITING
Haifa
Rabin MC
RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Ctr
RECRUITING
Tel Aviv
Italy
Irccs Istituto Nazionale Dei Tumori (Int)
RECRUITING
Milan
Istituto Nazionale Tumori Fondazione G. Pascale
WITHDRAWN
Napoli
A.O. Universitaria S. Luigi Gonzaga
RECRUITING
Orbassano
Policlinico Universitario Agostino Gemelli IRCCS
ACTIVE_NOT_RECRUITING
Rome
Japan
National Cancer Center Hospital East
RECRUITING
Chiba
Kindai University Hospital
RECRUITING
Osaka
National Cancer Center Hospital
RECRUITING
Tokyo
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Wakayama Medical University Hospital
RECRUITING
Wakayama
Netherlands
NKI The Netherlands Cancer Institute
ACTIVE_NOT_RECRUITING
Amsterdam
UMC St Radboud
RECRUITING
Nijmegen
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gda?sk
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
RECRUITING
Krakow
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
ACTIVE_NOT_RECRUITING
Olsztyn
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
ICO Badalona-H.U. Germans Trias i Pujol
RECRUITING
Badalona
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
ACTIVE_NOT_RECRUITING
Valencia
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Switzerland
Universitätsspital Basel
ACTIVE_NOT_RECRUITING
Basel
Inselspital Bern
WITHDRAWN
Bern
Taiwan
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan Uni Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation - Linkou
ACTIVE_NOT_RECRUITING
Taoyuan District
United Kingdom
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Barts & London School of Med
RECRUITING
London
Contact Information
Primary
Reference Study ID Number: BO44426 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2032-01-29
Participants
Target number of participants: 240
Treatments
Experimental: Cohort A - Combination Dose Finding + Dose Expansion
Participants will be enrolled in different cohorts to receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).~During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
Experimental: Cohort B - Combination Dose Finding + Dose Expansion
Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche