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
Launched by HOFFMANN-LA ROCHE · Jul 5, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called divarasib for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation known as KRAS G12C. The goal is to see if divarasib is safer and more effective than currently approved treatments like sotorasib or adagrasib. To participate, individuals must have already received at least one previous treatment for their cancer, have measurable disease, and provide a tumor sample that shows the KRAS G12C mutation.
Eligible participants should be between the ages of 65 and 74, have a good performance status (meaning they can carry out daily activities), and expect to live for at least 12 weeks. Throughout the trial, participants will receive regular check-ups to monitor their health and the effects of the treatment. This study is currently recruiting participants, and it's important to note that anyone with certain health conditions or a history of specific cancers may not be eligible. If you or a family member are interested in learning more about participating, consider discussing it with your healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
- • 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 advanced or 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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
New York, New York, United States
Lyon, , France
Boston, Massachusetts, United States
Sioux Falls, South Dakota, United States
Little Rock, Arkansas, United States
Liverpool, New South Wales, Australia
Paris, , France
Zaragoza, , Spain
Fort Myers, Florida, United States
Hong Kong, , Hong Kong
Boston, Massachusetts, United States
Miami, Florida, United States
Columbus, Ohio, United States
Houston, Texas, United States
Chicago, Illinois, United States
Chapel Hill, North Carolina, United States
Orange, California, United States
Portland, Oregon, United States
Nottingham, , United Kingdom
Barcelona, , Spain
Halle, , Germany
Ann Arbor, Michigan, United States
San Francisco, California, United States
Greenville, North Carolina, United States
Bruxelles, , Belgium
Montreal, Quebec, Canada
Lexington, Kentucky, United States
Khon Kaen, , Thailand
Valencia, , Spain
Essen, , Germany
Helsinki, , Finland
Fukuoka, , Japan
Niigata, , Japan
Okayama, , Japan
Herlev, , Denmark
Taipei, , Taiwan
Blackpool, , United Kingdom
Montpellier, , France
Elizabeth Vale, South Australia, Australia
Nashville, Tennessee, United States
Tokyo, , Japan
Athens, Georgia, United States
Hong Kong, , Hong Kong
Kaohsiung, , Taiwan
Porto Alegre, Rs, Brazil
Glasgow, , United Kingdom
Lille, , France
Muncie, Indiana, United States
Edegem, , Belgium
Hemer, , Germany
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Berlin, , Germany
Oldenburg, , Germany
Melbourne, Victoria, Australia
Leeds, , United Kingdom
Bron, , France
Madrid, , Spain
Bydgoszcz, , Poland
Brussel, , Belgium
Lublin, , Poland
Manchester, , United Kingdom
Busan, , Korea, Republic Of
Cambridge, , United Kingdom
West Palm Beach, Florida, United States
San Francisco, California, United States
Shizuoka, , Japan
Buenos Aires, , Argentina
Aalst, , Belgium
Los Angeles, California, United States
Immenhausen, , Germany
New Haven, Connecticut, United States
Warszawa, , Poland
Liège, , Belgium
Barretos, Sp, Brazil
Angers, , France
Pittsburgh, Pennsylvania, United States
Esslingen, , Germany
Lübeck, , Germany
Pessac, , France
Regensburg, , Germany
Heidelberg, , Germany
Großhansdorf, , Germany
Hasselt, , Belgium
Scarborough, Maine, United States
Incheon, , Korea, Republic Of
Barcelona, , Spain
Breda, , Netherlands
Grand Rapids, Michigan, United States
Toulouse, , France
Songkhla, , Thailand
Berlin, , Germany
Tokyo, , Japan
Jeollanam Do, , Korea, Republic Of
Salvador, Ba, Brazil
Strasbourg, , France
Buenos Aires, , Argentina
Jacksonville, Florida, United States
Seoul, , Korea, Republic Of
Pinehurst, North Carolina, United States
'S Hertogenbosch, , Netherlands
Wilrijk, , Belgium
München, , Germany
Hokkaido, , Japan
Braunschweig, , Germany
Aarhus N, , Denmark
Seoul, , Korea, Republic Of
Roeselare, , Belgium
Guadalajara, Jalisco, Mexico
Cottingham, , United Kingdom
Savannah, Georgia, United States
Esslingen, , Germany
Gdansk, , Poland
London, , United Kingdom
Arnhem, , Netherlands
Malaga, , Spain
Brest, , France
Daegu, , Korea, Republic Of
Regensburg, , Germany
Gävle, , Sweden
Osaka, , Japan
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Sao Jose Do Rio Preto, Sp, Brazil
Madrid, , Spain
Braga, , Portugal
Daegu, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Birtinya, Queensland, Australia
Toronto, Ontario, Canada
Parma, Emilia Romagna, Italy
Sutton, , United Kingdom
Saint Quentin, , France
Saint Petersburg, Florida, United States
Memphis, Tennessee, United States
Mont Godinne, , Belgium
Fort Worth, Texas, United States
Hong Kong, , Hong Kong
Halle, , Germany
Homburg, , Germany
Pisa, Toscana, Italy
Saint Augustine, Florida, United States
Eugene, Oregon, United States
Darlinghurst, New South Wales, Australia
Zwolle, , Netherlands
Bergamo, Lombardia, Italy
Gyeonggi Do, , Korea, Republic Of
Gyeongsangnam Do, , Korea, Republic Of
Stoke On Trent, , United Kingdom
Homburg, , Germany
Novara, Piemonte, Italy
Wakayama, , Japan
Gauting, , Germany
Seville, Sevilla, Spain
Genova, Liguria, Italy
Poznan, , Poland
Aarhus N, , Denmark
Ehime, , Japan
Hong Kong, , Hong Kong
Bron, , France
Harderwijk, , Netherlands
Bangkok, , Thailand
Cardiff, , United Kingdom
Hospitalet De Llobregat, Barcelona, Spain
Darlinghurst, New South Wales, Australia
Spartanburg, South Carolina, United States
Essen, , Germany
Würzburg, , Germany
Omaha, Nebraska, United States
Münster, , Germany
Sint Niklaas, , Belgium
Bronx, New York, United States
Wien, , Austria
Sao Paulo, , Brazil
Rio De Janeiro, Rj, Brazil
St Leonards, New South Wales, Australia
Ciudad Autonoma Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Rosario, , Argentina
Birtinya, Queensland, Australia
Herning, , Denmark
Porto Alegre, Rio Grande Do Sul, Brazil
Leidschendam, , Netherlands
Heroica Puebla De Zaragoza, Puebla, Mexico
New York, New York, United States
Radom, , Poland
Palermo, Sicilia, Italy
Toulon, , France
Faliro, , Greece
Hsinchu City, , Taiwan
Poznan, , Poland
Methuen, Massachusetts, United States
Los Angeles, California, United States
Ciudad Autonoma Buenos Aires, , Argentina
Lisboa, , Portugal
Gilbert, Arizona, United States
Longview, Texas, United States
New Hyde Park, New York, United States
Porto Alegre, Rs, Brazil
Olsztyn, , Poland
Bologna, Emilia Romagna, Italy
?ód?, , Poland
Strasbourg, , France
Udine, Friuli Venezia Giulia, Italy
Columbus, Ohio, United States
Reno, Nevada, United States
Sao Jose Do Rio Preto, São Paulo, Brazil
Singapore, , Singapore
Thessaloniki, , Greece
Taipei, , Taiwan
Foxboro, Massachusetts, United States
Ciudad De México, , Mexico
Porto Alegre, Rs, Brazil
Miyagi, , Japan
Sao Paulo, São Paulo, Brazil
Des Moines, Iowa, United States
Taichung, , Taiwan
Brasilia, Df, Brazil
Sao Paulo, Sp, Brazil
Brampton, Ontario, Canada
Maumee, Ohio, United States
Warszawa, , Poland
Wien, , Austria
Santiago De Querétaro, Queretaro, Mexico
Elizabeth Vale, South Australia, Australia
Gävle, , Sweden
Taichung, , Taiwan
Sao Paulo, São Paulo, Brazil
Bari, Puglia, Italy
Porto, , Portugal
Lublin, , Poland
Olsztyn, , Poland
Wroc?Aw, , Poland
Porto, , Portugal
Torquay, , United Kingdom
Salvador, Bahia, Brazil
Roma, Lazio, Italy
Taoyuan, , Taiwan
Ravenna, Emilia Romagna, Italy
Firenze, Toscana, Italy
Barretos, São Paulo, Brazil
Kraków, , Poland
Ciudad Autonoma Buenos Aires, , Argentina
Turku, , Finland
Warszawa, , Poland
Porto Alegre, Rio Grande Do Sul, Brazil
Larissa, , Greece
Louisville, Kentucky, United States
Shirley, New York, United States
Chattanooga, Tennessee, United States
Wien, , Austria
Brasilia, Distrito Federal, Brazil
Campo Grande, Mato Grosso Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Nice, , France
Berlin, , Germany
Essen, , Germany
Kiel, , Germany
Köln, , Germany
Löwenstein, , Germany
Mannheim, , Germany
Athens, , Greece
Athens, , Greece
Thessaloniki, , Greece
Shatin, , Hong Kong
Catanzaro, Calabria, Italy
Rozzano (Mi), Lombardia, Italy
Sassari, Sardegna, Italy
Palermo, Sicilia, Italy
Padova, Veneto, Italy
Saltillo, Coahuila, Mexico
?ód?, , Poland
Coimbra, , Portugal
Singapore, , Singapore
Bangkok, , Thailand
London, , United Kingdom
Kuopio, , Finland
Detroit, Michigan, United States
Aalst, , Belgium
Colorado Springs, Colorado, United States
Bay Pines, Florida, United States
Richmond, Virginia, United States
Waukee, Iowa, United States
Shreveport, Louisiana, United States
Barretos, , Brazil
Sao Paulo, , Brazil
Sao Jose Do Rio Preto, , Brazil
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported