Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-04-20
320
Participants Needed
71
Research Sites
449 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmation of biomarker eligibility
- Pre-treatment tumor tissue and pathology report required, with formalin-fixed, paraffin-embedded blocks or 15 unstained slides (minimum 10 slides possible after sponsor consultation)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC not eligible for curative surgery or definitive chemoradiotherapy
- No prior systemic treatment for advanced unresectable or metastatic NSCLC
- Measurable disease per RECIST v1.1; for cohort D, measurable asymptomatic brain metastases between 5 mm and less than 20 mm not requiring local therapy
You will not qualify if you...
- Known second oncogenic driver with available targeted treatment
- Squamous cell histology NSCLC
- Symptomatic, untreated, or actively progressing central nervous system metastases (Cohorts A, B, and C)
- Prior treatment with a KRAS G12C inhibitor
- Known hypersensitivity to divarasib, pembrolizumab, pemetrexed, carboplatin, or cisplatin (for Cohort B)
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, active pneumonitis, active tuberculosis, or significant cardiovascular disease within 3 months before study treatment
- History of malignancy other than NSCLC within 5 years except certain low-risk cancers
- Uncontrolled tumor-related pain, pleural or pericardial effusion, ascites needing recurrent drainage, or symptomatic hypercalcemia
- Co-morbid conditions that contraindicate corticosteroid treatment
- Inability or unwillingness to take required prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12
- Brain metastases suitable for complete surgical resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 71 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Withdrawn
2
City of Hope - Seacliff
Huntington Beach, California, United States, 92648
Withdrawn
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Withdrawn
4
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Withdrawn
5
City of Hope - Long Beach Elm
Long Beach, California, United States, 90813
Withdrawn
6
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
7
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Fort Myers, Florida, United States, 33901-8108
Actively Recruiting
8
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, United States, 33705-1400
Actively Recruiting
9
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida, United States, 33401-3406
Actively Recruiting
10
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
11
NYU Cancer Center
New York, New York, United States, 10016
Actively Recruiting
12
Mount SInai Medical Center
New York, New York, United States, 10029
Actively Recruiting
13
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, United States, 10461
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia, United States, 24060
Actively Recruiting
16
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
17
Hospital Britanico
Buenos Aires, Argentina, C1280AEB
Actively Recruiting
18
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
Actively Recruiting
19
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300COE
Actively Recruiting
20
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Completed
21
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
22
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
23
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Actively Recruiting
24
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium, 3500
Actively Recruiting
25
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Actively Recruiting
26
AZ Delta (Campus Rumbeke)
Roeselare, Belgium, 8800
Actively Recruiting
27
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
28
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
29
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8M2
Actively Recruiting
30
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1Z5
Active, Not Recruiting
31
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
32
Hunan Cancer Hospital
Changsha, China, 410013
Active, Not Recruiting
33
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
34
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Active, Not Recruiting
35
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
36
Rabin MC
Petah Tikva, Israel, 4941492
Actively Recruiting
37
Tel Aviv Sourasky Medical Ctr
Tel Aviv, Israel, 6423906
Actively Recruiting
38
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Campania, Italy, 80131
Withdrawn
39
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 00168
Active, Not Recruiting
40
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy, 20133
Actively Recruiting
41
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont, Italy, 10043
Actively Recruiting
42
National Cancer Center Hospital East
Chiba, Japan, 277-8577
Actively Recruiting
43
Kindai University Hospital
Osaka, Japan, 589-8511
Actively Recruiting
44
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
45
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
46
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
47
NKI The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Active, Not Recruiting
48
UMC St Radboud
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
49
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland, 80-214
Actively Recruiting
50
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow, Poland, 31-202
Actively Recruiting
51
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, Poland, 10-357
Active, Not Recruiting
52
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
53
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
54
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
55
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
56
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
57
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
58
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain, 08035
Actively Recruiting
59
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
60
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
61
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
62
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
63
Sahlgrenska University Hospital
Gothenburg, Sweden, 411 36
Actively Recruiting
64
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
65
Inselspital Bern
Bern, Switzerland, 3010
Withdrawn
66
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Actively Recruiting
67
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
68
National Taiwan Uni Hospital
Taipei, Taiwan, 100
Actively Recruiting
69
Chang Gung Medical Foundation - Linkou
Taoyuan, Taiwan, 333
Active, Not Recruiting
70
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
71
Barts & London School of Med
London, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
R
Reference Study ID Number: BO44426 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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