Trial Title:
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib 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
NCT ID:
NCT05789082
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Divarasib
Description:
Participants will receive one of two doses of divarasib orally (PO), QD on days 1-21 of
each 21-day cycle.
Arm group label:
Cohort A - Combination Dose Finding + Dose Expansion
Arm group label:
Cohort B - Combination Dose Finding + Dose Expansion
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each
21-day cycle.
Arm group label:
Cohort A - Combination Dose Finding + Dose Expansion
Arm group label:
Cohort B - Combination Dose Finding + Dose Expansion
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Participants will receive IV carboplatin Q3W for four 21-day cycles.
Arm group label:
Cohort B - Combination Dose Finding + Dose Expansion
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Participants will receive IV cisplatin Q3W for four 21-day cycles.
Arm group label:
Cohort B - Combination Dose Finding + Dose Expansion
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Participants will receive IV pemetrexed Q3W.
Arm group label:
Cohort B - Combination Dose Finding + Dose Expansion
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).
Criteria for eligibility:
Criteria:
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
Exclusion Criteria:
- Known concomitant second oncogenic driver with available targeted treatment
- Squamous cell histology NSCLC
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCSD Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Hospital - Long Island
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Cancer Center; NYU Cancer Institute
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center; Oncology
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Hospital Britanico; Oncologia
Address:
City:
Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Clinica Adventista Belgrano; Oncology
Address:
City:
Ciudad Autonoma Buenos Aires
Zip:
C1430EGF
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro Oncologico Riojano Integral (CORI)
Address:
City:
La Rioja
Zip:
F5300COE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Concord Repatriation General Hospital; Concord Cancer Centre
Address:
City:
Concord
Zip:
2139
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre; Medical Oncology
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires St-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Jessa Zkh (Campus Virga Jesse)
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Clinique Ste-Elisabeth
Address:
City:
Namur
Zip:
5000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
AZ Delta (Campus Rumbeke)
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Crio - Centro Regional Integrado de Oncologia
Address:
City:
Fortaleza
Zip:
60336-232
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Hospital Nossa Senhora da Conceicao
Address:
City:
Porto Alegre
Zip:
90040-373
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo - ICESP
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Active, not recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Active, not recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha CITY
Zip:
410013
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Rambam Medical Center; Oncology
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin MC; Davidof Center - Oncology Institute
Address:
City:
Petach Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Ctr; Oncology
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Facility:
Name:
Pusan National University Hospital
Address:
City:
Busan
Zip:
602-739
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
NKI The Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Active, not recruiting
Facility:
Name:
UMC St Radboud
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Address:
City:
Gda?sk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny
Address:
City:
Kraków
Zip:
31-202
Country:
Poland
Status:
Recruiting
Facility:
Name:
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Address:
City:
Olsztyn
Zip:
10-357
Country:
Poland
Status:
Active, not recruiting
Facility:
Name:
ICO Badalona-H.U. Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
NEXT Oncology-Hospital Quironsalud Madrid
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of Oncology
Address:
City:
Göteborg
Zip:
413 45
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Universitätsspital Basel; Oncology - Klinische Forschung
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Active, not recruiting
Facility:
Name:
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital; Internal Medicine
Address:
City:
North Dist.
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital; Dept of Internal Medicine
Address:
City:
Taichung
Zip:
407
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan Uni Hospital; Internal Medicine
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Medical Foundation - Linkou; Chest Dept
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Active, not recruiting
Facility:
Name:
Adana City Hospital, Medical Oncology
Address:
City:
Adana
Zip:
01060
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Ankara
Zip:
06490
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Koc University Hospital; Oncology
Address:
City:
Istanbul
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Barts & London School of Med; Medical Oncology
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Start date:
June 20, 2023
Completion date:
May 20, 2027
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789082
