Trial Title:
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT06497556
Condition:
Non-Small Cell Lung Cancer
KRAS G12C Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Sotorasib
Adagrasib
Conditions: Keywords:
Advanced Non-Small Cell Lung Cancer
KRAS G12 Lung Cancer
Advanced Lung Cancer
Metastatic lung cancer
Divarasib
KRAS G12C Inhibitor
KRAS G12C Positive
KRAS Mutation
KRAS G12C Mutation
Lung Cancer Mutation
Study type:
Interventional
Study phase:
Phase 3
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:
Divarasib will be administered orally QD
Arm group label:
Divarasib
Intervention type:
Drug
Intervention name:
Sotorasib
Description:
Sotorasib will be administered orally QD
Arm group label:
KRAS G12C inhibitor
Intervention type:
Drug
Intervention name:
Adagrasib
Description:
Adagrasib will be administred orally BID
Arm group label:
KRAS G12C inhibitor
Summary:
The purpose of this study is to assess the safety and efficacy of divarasib compared to
locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS
G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Unequivocal histologically or cytologically confirmed diagnosis of unresectable
Stage IIIc, per the American Joint Committee on Cancer staging system (AJCC) (Amin
et al. 2017) not amenable to treatment with combined modality chemoradiation
(advanced) or Stage IV (metastatic) NSCLC
- Disease progression during or after treatment with at least one prior systemic
therapy but no more than three lines of prior systemic therapy in the metastatic
setting
- Measurable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1
- Documentation of the presence of a KRAS G12C mutation
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor
specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly
cut, serial slides with an associated pathology report
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of >= 12 weeks
Exclusion Criteria:
- Known hypersensitivity to any of the components of divarasib, or sotorasib or
adagrasib
- Malabsorption syndrome or other condition that would interfere with enteral
absorption
- Known concomitant second oncogenic driver
- Mixed small-cell lung cancer or large cell neuroendocrine histology
- Known and untreated, or active central nervous system (CNS) metastases
- Leptomeningeal disease or carcinomatous meningitis
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures biweekly or more frequently
- Any infection that, in the opinion of the investigator, could impact patient safety,
or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1
of Cycle 1
- Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
- More than 30 Gy of radiotherapy to the lung within 6 months of randomization
- Uncontrolled tumor-related pain
- Unresolved toxicities from prior anticancer therapy
- History of malignancy within 5 years prior to screening, with the exception of the
cancer under investigation in this study and malignancies with a negligible risk of
metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated
carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate
cancer, ductal carcinoma in situ, or Stage I uterine cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner Health MD Anderson AZ
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Specialists of North Florida
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
New England Cancer Specialists
Address:
City:
Scarborough
Zip:
04074
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Methodist Estabrook Cancer Center
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Clinical Research Institute
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
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:
Centro Oncologico Korben; Oncology
Address:
City:
Ciudad Autonoma Buenos Aires
Zip:
C1426AGE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Kinghorn Cancer Centre; St Vincents Hospital
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
GenesisCare North Shore
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sunshine Coast University Hospital; The Adem Crosby Centre
Address:
City:
Birtinya
Zip:
4575
Country:
Australia
Status:
Recruiting
Facility:
Name:
Lyell McEwin Hospital; Clinical Trials Unit
Address:
City:
Elizabeth Vale
Zip:
5112
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter Maccallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hospital Sao Rafael - HSR
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Brasilia
Address:
City:
Brasilia
Zip:
71635580
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Oncoclinicas Rio de Janeiro S.A.
Address:
City:
Rio de Janeiro
Zip:
22250-905
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Santa Casa de Misericordia de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90020-090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Nossa Senhora da Conceicao
Address:
City:
Porto Alegre
Zip:
90040-373
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Mae de Deus
Address:
City:
Porto Alegre
Zip:
90110-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Base de Sao Jose do Rio Preto
Address:
City:
Sao Jose do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Alemao Oswaldo Cruz
Address:
City:
Sao Paulo
Zip:
01327-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Aarhus Universitetshospital; Kræftafdelingen
Address:
City:
Aarhus N
Zip:
8200
Country:
Denmark
Status:
Recruiting
Facility:
Name:
CHU Montpellier
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Recruiting
Facility:
Name:
CHRU DE STRASBOURG; Département d?Hématologie et Oncologie
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Facility:
Name:
Chu Toulouse
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Essen; Innere Klinik (Tumorforschung)
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Address:
City:
Esslingen
Zip:
73730
Country:
Germany
Status:
Recruiting
Facility:
Name:
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universität Des Saarlandes; Klinik für Innere Medizin V
Address:
City:
Homburg
Zip:
66421
Country:
Germany
Status:
Recruiting
Facility:
Name:
Lungenfachklinik Immenhausen
Address:
City:
Immenhausen
Zip:
34376
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
Hong Kong Integrated Oncology Centre
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital; Dept. of Clinical Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello; Dip. Ematologia e Oncologia
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Recruiting
Facility:
Name:
Pusan National University Hospital
Address:
City:
Busan
Zip:
602-739
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Keimyung University Dongsan Medical Center
Address:
City:
Daegu
Zip:
41931
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
St. Vincent's Hospital
Address:
City:
Gyeonggi-do
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pusan National University Yangsan Hospital
Address:
City:
Gyeongsangnam-do
Zip:
50612
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Jeollanam-do
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
463-707
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
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:
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:
Instytut "Centrum Zdrowia Matki Polki"; Klinika Onkologii
Address:
City:
?ód?
Zip:
93-338
Country:
Poland
Status:
Recruiting
Facility:
Name:
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Address:
City:
Lublin
Zip:
20-954
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:
Recruiting
Facility:
Name:
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej
Address:
City:
Poznan
Zip:
60-569
Country:
Poland
Status:
Recruiting
Facility:
Name:
Radomskie Centrum Onkologii
Address:
City:
Radom
Zip:
26-600
Country:
Poland
Status:
Recruiting
Facility:
Name:
Instytut Gruzlicy I Chorob Pluc; Iii Klinika Chorob Pluc
Address:
City:
Warszawa
Zip:
01-138
Country:
Poland
Status:
Recruiting
Facility:
Name:
Gävle Sjukhus; Medicinskt Centrum
Address:
City:
Gävle
Zip:
80187
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung City
Zip:
807
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chung Shan Medical University Hospital; Department of Chest
Address:
City:
Taichung
Zip:
402306
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital; Internal Medicince
Address:
City:
Taipei
Zip:
00100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital - London
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Start date:
September 23, 2024
Completion date:
September 30, 2029
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Collaborator:
Agency:
Chugai Pharmaceutical
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/NCT06497556
